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CompletedNCT03990051Updated May 6, 2025Results posted

Treatment Safety and Efficacy of Pro-ocular™ 1% for Chronic Ocular Graft Following Allogeneic HSCT.

A Phase 2 interventional study of Pro-ocular™ topical gel and Placebo topical gel in Chronic Ocular Graft-versus-host Disease, sponsored by Glia, LLC. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-06.

Sponsored by Glia, LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

To evaluate the safety and efficacy of Pro-ocular™ 1% topical gel administered twice daily for 70 days in reducing or eliminating symptoms and signs of chronic ocular GvHD.

Read the detailed description

Ocular graft versus host disease presents a most severe form of ocular surface disease that compromises quality of life of afflicted allogeneic hematopoietic transplantation patients.

A controlled study is necessary to verify findings obtained to date in isolated patients. Currently available ophthalmic solutions and suspensions, drugs and devices largely have not been effective in alleviating the suffering of chronic ocular GvHD patients. Thus, this is an unmet need that Pro-ocular™ topical gel can fulfill.

Potential benefits: Decrease or cessation of adverse ocular symptoms and signs of chronic ocular GvHD, reduction or elimination of the need for other topical ocular therapeutic treatments for chronic ocular GvHD, and restoration of quality of life.

02

Conditions studied

  • Chronic Ocular Graft-versus-host Disease

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03

In context

Graft vs Host Disease

806 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.

This study's enrollment of 33 is close to the median of 35 across 637 interventional studies indexed under Graft vs Host Disease.

Browse Graft vs Host Disease studies →

Lead sponsor

Glia, LLC is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female of any race, at least 18 years of age at Visit 1 Screening.
  2. Has the diagnosis of chronic ocular GvHD.
  3. Has an NIH Consensus Eye Score of at least 2.
  4. On the GLIA Ocular Surface Disease Symptoms Questionnaire at Screening, has ocular discomfort at a severity score of moderate or more, and at least one other symptom at a severity of moderate or more.
  5. One or more signs from the list of chronic ocular GvHD signs below
  6. Has provided verbal and written informed consent.
  7. Be able and willing to follow oral and written instructions, including participation in all study assessments and visits.

Exclusion criteria

Exclusion Criteria:

  1. Wearing scleral or contact lenses within the last month, or those who plan to start wearing scleral or contact lenses during the study.
  2. Anticipate major changes in systemic GvHD management during study period.
  3. Comorbidity with other severe or chronic eye conditions that in the judgment of the investigator will interfere with study assessments, such as but not limited to retinal detachment, recent ocular surgery, Bell's palsy, active trigeminal neuritis or trigeminal neuralgia.
  4. Anticipate change of vision correction or anticipate any ocular procedures during study period.
  5. A woman who is pregnant, nursing an infant, or planning a pregnancy.
  6. A woman of childbearing potential who has a positive urine pregnancy test at Visit 1, or who does not use an adequate method of birth control throughout the study period.
  7. Has a known adverse reaction and/or sensitivity to the study drug or its components.
  8. Unwilling to cease the use of sunscreen on the forehead or eye area.
  9. Intraocular pressure >22 mm Hg at screening visit with or without ongoing glaucoma treatment.
  10. Currently enrolled in an investigational drug or device study for chronic ocular GvHD.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    Pro-ocular™

    Pro-ocular™ 1% topical gel applied dermally to forehead twice daily, morning and before bedtime.

    Drug: Pro-ocular™ topical gel

  • Placebo comparator
    Placebo

    Vehicle topical gel without active ingredient applied dermally to forehead twice daily, morning and before bedtime.

    Drug: Placebo topical gel

Interventions

  • DrugPro-ocular™ topical gel

    Topical gel for forehead dermal application

  • DrugPlacebo topical gel

    Topical gel for forehead dermal application

06

What researchers measure

Primary outcomes

  1. Modified SANDE Questionnaire - Frequency, Change From Baseline

    Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?

    Time frame: 2 weeks

  2. Corneal Fluorescein Stain - Central, Change From Baseline

    Change in score from Baseline for worse eye. Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.

    Time frame: 2 weeks

Secondary outcomes

  1. Modified SANDE Questionnaire - Frequency, Change From Baseline

    Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?

    Time frame: 6 weeks

  2. Modified SANDE Questionnaire - Frequency, Change From Baseline

    Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?

    Time frame: 10 weeks

  3. Corneal Fluorescein Stain - Central, Change From Baseline

    Change in score from Baseline for worse eye. Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.

    Time frame: 6 weeks

  4. Corneal Fluorescein Stain - Central, Change From Baseline

    Change in score from Baseline for worse eye. Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.

    Time frame: 10 weeks

  5. Modified SANDE Questionnaire - Global, Change From Baseline

    Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated? Global score is sqrt of Frequency x Severity.

    Time frame: 2 weeks

  6. Modified SANDE Questionnaire - Global, Change From Baseline

    Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated? Global score is sqrt of Frequency x Severity.

    Time frame: 6 weeks

  7. Modified SANDE Questionnaire - Global, Change From Baseline

    Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated? Global score is sqrt of Frequency x Severity.

    Time frame: 10 weeks

  8. Corneal Fluorescein Stain - Total, Change From Baseline

    Change in score from Baseline for worse eye. Fluorescein staining score in Total comprise Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.

    Time frame: 2 weeks

  9. Corneal Fluorescein Stain - Total, Change From Baseline

    Change in score from Baseline for worse eye. Fluorescein staining score in Total comprise Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.

    Time frame: 6 weeks

  10. Corneal Fluorescein Stain - Total, Change From Baseline

    Change in score from Baseline for worse eye. Fluorescein staining score in Total comprise Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.

    Time frame: 10 weeks

  11. Blurred Vision, Change From Baseline

    Change in score from Baseline for worse eye. Score measured from visual analog scale 0-10, higher values represent worse outcomes. Blurred vision symptom is reported by participant.

    Time frame: 2 weeks

  12. Blurred Vision, Change From Baseline

    Change in score from Baseline for worse eye. Score measured from visual analog scale 0-10, higher values represent worse outcomes. Blurred vision symptom is reported by participant.

    Time frame: 6 weeks

  13. Blurred Vision, Change From Baseline

    Change in score from Baseline for worse eye. Score measured from visual analog scale 0-10, higher values represent worse outcomes. Blurred vision symptom is reported by participant.

    Time frame: 10 weeks

  14. Photophobia, Change From Baseline

    Change in score from Baseline for worse eye. Score is recorded on a visual analog scale 0-10, higher values represent worse outcomes. Sensitivity to light symptom is reported by participant.

    Time frame: 2 weeks

  15. Photophobia, Change From Baseline

    Change in score from Baseline for worse eye. Score is recorded on a visual analog scale 0-10, higher values represent worse outcomes. Sensitivity to light symptom is reported by participant.

    Time frame: 6 weeks

  16. Photophobia, Change From Baseline

    Change in score from Baseline for worse eye. Score is recorded on a visual analog scale 0-10, higher values represent worse outcomes. Sensitivity to light symptom is reported by participant.

    Time frame: 10 weeks

  17. Lid Edema, Change From Baseline

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid edema is viewed by slit lamp without stain.

    Time frame: 2 weeks

  18. Lid Edema, Change From Baseline

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid edema is viewed by slit lamp without stain.

    Time frame: 6 weeks

  19. Lid Edema, Change From Baseline

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid edema is viewed by slit lamp without stain.

    Time frame: 10 weeks

  20. Lid Erythema, Change From Baseline

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid erythema is viewed by slit lamp without stain.

    Time frame: 2 weeks

  21. Lid Erythema, Change From Baseline

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid erythema is viewed by slit lamp without stain.

    Time frame: 6 weeks

  22. Lid Erythema, Change From Baseline

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid erythema is viewed by slit lamp without stain.

    Time frame: 10 weeks

  23. Lid Margin Ulceration, Change From Baseline

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid margin ulceration is viewed by slit lamp without stain.

    Time frame: 2 weeks

  24. Lid Margin Ulceration, Change From Baseline

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid margin ulceration is viewed by slit lamp without stain.

    Time frame: 6 weeks

  25. Lid Margin Ulceration, Change From Baseline

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid margin ulceration is viewed by slit lamp without stain.

    Time frame: 10 weeks

  26. Conjunctival Hyperemia, Change From Baseline

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Conjunctival hyperemia is viewed by slit lamp without stain.

    Time frame: 2 weeks

  27. Conjunctival Hyperemia, Change From Baseline

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Conjunctival hyperemia is viewed by slit lamp without stain.

    Time frame: 6 weeks

  28. Conjunctival Hyperemia, Change From Baseline

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Conjunctival hyperemia is viewed by slit lamp without stain.

    Time frame: 10 weeks

  29. Dryness, Change From Baseline

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Dryness symptom is reported by participant.

    Time frame: 2 weeks

  30. Dryness, Change From Baseline

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Dryness symptom is reported by participant.

    Time frame: 6 weeks

  31. Dryness, Change From Baseline

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Dryness symptom is reported by participant.

    Time frame: 10 weeks

  32. Ocular Pain, Change From Baseline

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Ocular pain symptom is reported by participant.

    Time frame: 2 weeks

  33. Ocular Pain, Change From Baseline

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Ocular pain symptom is reported by participant.

    Time frame: 6 weeks

  34. Ocular Pain, Change From Baseline

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Ocular pain symptom is reported by participant.

    Time frame: 10 weeks

  35. Airflow Sensitivity, Change From Baseline

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Airflow sensitivity symptom is reported by participant.

    Time frame: 2 weeks

  36. Airflow Sensitivity, Change From Baseline

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Airflow sensitivity symptom is reported by participant.

    Time frame: 6 weeks

  37. Airflow Sensitivity, Change From Baseline

    Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Airflow sensitivity symptom is reported by participant.

    Time frame: 10 weeks

Other outcomes

  1. Modified SANDE Questionnaire - Frequency

    Score on a visual analog scale 0-100, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?

    Time frame: 1 year

  2. Modified SANDE Questionnaire - Frequency

    Score on a visual analog scale 0-100, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?

    Time frame: 2 years

  3. Modified SANDE Questionnaire - Global

    Score on a visual analog scale 0-100, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. Global score is square root of how often do eyes feel dry and/or irritated x how severe are your symptoms of dryness and/or irritation?

    Time frame: 1 year

  4. Modified SANDE Questionnaire - Global

    Score on a visual analog scale 0-100, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. Global score is square root of how often do eyes feel dry and/or irritated x how severe are your symptoms of dryness and/or irritation?

    Time frame: 2 years

  5. Corneal Fluorescein Stain - Central

    Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.

    Time frame: 1 year

  6. Corneal Fluorescein Stain - Central

    Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.

    Time frame: 2 years

  7. Corneal Fluorescein Stain - Total

    Fluorescein staining score Total for worse eye. Total comprise Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.

    Time frame: 1 year

  8. Corneal Fluorescein Stain - Total

    Fluorescein staining score Total for worse eye. Total comprises Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.

    Time frame: 2 years

  9. Blurred Vision

    Score for worse eye, recorded on a visual analog scale 0-10, higher values represent worse outcomes. Blurred vision symptom is reported by participant.

    Time frame: 1 year

  10. Blurred Vision

    Score for worse eye, recorded on a visual analog scale 0-10, higher values represent worse outcomes. Blurred vision symptom is reported by participant.

    Time frame: 2 years

  11. Lid Edema

    Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Lid edema is scored by ophthalmologist using slit lamp biomicroscopy without staining.

    Time frame: 1 year

  12. Lid Edema

    Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Lid edema is scored by ophthalmologist using slit lamp biomicroscopy without staining.

    Time frame: 2 years

  13. Lid Erythema

    Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Lid erythema is scored by ophthalmologist using slit lamp biomicroscopy without staining.

    Time frame: 1 year

  14. Lid Erythema

    Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Lid erythema is scored by ophthalmologist using slit lamp biomicroscopy without staining.

    Time frame: 2 years

  15. Lid Ulceration

    Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Lid ulceration is scored by ophthalmologist using slit lamp biomicroscopy without staining.

    Time frame: 1 year

  16. Lid Ulceration

    Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Lid erythema is scored by ophthalmologist using slit lamp biomicroscopy without staining.

    Time frame: 2 years

  17. Conjunctival Hyperemia

    Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Conjunctival hyperemia is scored by ophthalmologist using slit lamp biomicroscopy without staining.

    Time frame: 1 year

  18. Conjunctival Hyperemia

    Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Conjunctival hyperemia is scored by ophthalmologist using slit lamp biomicroscopy without staining.

    Time frame: 2 years

07

Results

Posted May 6, 2025

Participant flow

Double masked phase 10 weeks. Both Pro-ocular and Placebo groups received active treatment after 10 weeks for remainder of 2 years total from first dose..

Masked Period
Participant flow — Masked Period
MilestonePro-ocular™Placebo
Started2211
Completed2111
Not completed10
Withdrew: Lost to follow-up10
Long Term Period
Participant flow — Long Term Period
MilestonePro-ocular™Placebo
Started2111
Completed138
Not completed83
Withdrew: Death11
Withdrew: Lost to follow-up72

Outcome measures

PrimaryModified SANDE Questionnaire - Frequency, Change From Baseline

Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?

Time frame:
2 weeks
Reported as:
Least squares mean · score on a scale
Modified SANDE Questionnaire - Frequency, Change From Baseline
score on a scalePro-ocular™Placebo
Modified SANDE Questionnaire - Frequency, Change From Baseline-22.00 ± 4.246-4.59 ± 6.009
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.0197
PrimaryCorneal Fluorescein Stain - Central, Change From Baseline

Change in score from Baseline for worse eye. Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.

Time frame:
2 weeks
Reported as:
Least squares mean · score on a scale
Corneal Fluorescein Stain - Central, Change From Baseline
score on a scalePro-ocular™Placebo
Corneal Fluorescein Stain - Central, Change From Baseline-0.90 ± 0.2130.20 ± 0.304
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.0039
SecondaryModified SANDE Questionnaire - Frequency, Change From Baseline

Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?

Time frame:
6 weeks
Reported as:
Least squares mean · score on a scale
Modified SANDE Questionnaire - Frequency, Change From Baseline
score on a scalePro-ocular™Placebo
Modified SANDE Questionnaire - Frequency, Change From Baseline-31.75 ± 4.313-1.95 ± 6.009
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = <0.0001
SecondaryModified SANDE Questionnaire - Frequency, Change From Baseline

Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?

Time frame:
10 weeks
Reported as:
Least squares mean · score on a scale
Modified SANDE Questionnaire - Frequency, Change From Baseline
score on a scalePro-ocular™Placebo
Modified SANDE Questionnaire - Frequency, Change From Baseline-30.72 ± 4.313-2.18 ± 6.009
Statistical analysis
  • Pro-ocular™ vs Placebo · ANCOVA · p = 0.0002
SecondaryCorneal Fluorescein Stain - Central, Change From Baseline

Change in score from Baseline for worse eye. Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.

Time frame:
6 weeks
Reported as:
Least squares mean · score on a scale
Corneal Fluorescein Stain - Central, Change From Baseline
score on a scalePro-ocular™Placebo
Corneal Fluorescein Stain - Central, Change From Baseline-0.93 ± 0.216-0.01 ± 0.304
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.0138
SecondaryCorneal Fluorescein Stain - Central, Change From Baseline

Change in score from Baseline for worse eye. Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.

Time frame:
10 weeks
Reported as:
Least squares mean · score on a scale
Corneal Fluorescein Stain - Central, Change From Baseline
score on a scalePro-ocular™Placebo
Corneal Fluorescein Stain - Central, Change From Baseline-1.18 ± 0.2160.06 ± 0.307
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.0014
SecondaryModified SANDE Questionnaire - Global, Change From Baseline

Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated? Global score is sqrt of Frequency x Severity.

Time frame:
2 weeks
Reported as:
Least squares mean · score on a scale
Modified SANDE Questionnaire - Global, Change From Baseline
score on a scalePro-ocular™Placebo
Modified SANDE Questionnaire - Global, Change From Baseline-16.02 ± 4.063-3.78 ± 5.753
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.0849
SecondaryModified SANDE Questionnaire - Global, Change From Baseline

Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated? Global score is sqrt of Frequency x Severity.

Time frame:
6 weeks
Reported as:
Least squares mean · score on a scale
Modified SANDE Questionnaire - Global, Change From Baseline
score on a scalePro-ocular™Placebo
Modified SANDE Questionnaire - Global, Change From Baseline-26.35 ± 4.128-5.64 ± 5.753
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.0041
SecondaryModified SANDE Questionnaire - Global, Change From Baseline

Change in score from Baseline for worse eye. Score is 0-100 on a visual analog scale, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated? Global score is sqrt of Frequency x Severity.

Time frame:
10 weeks
Reported as:
Least squares mean · score on a scale
Modified SANDE Questionnaire - Global, Change From Baseline
score on a scalePro-ocular™Placebo
Modified SANDE Questionnaire - Global, Change From Baseline-25.87 ± 4.128-1.04 ± 0.006
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.0006
SecondaryCorneal Fluorescein Stain - Total, Change From Baseline

Change in score from Baseline for worse eye. Fluorescein staining score in Total comprise Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.

Time frame:
2 weeks
Reported as:
Least squares mean · score on a scale
Corneal Fluorescein Stain - Total, Change From Baseline
score on a scalePro-ocular™Placebo
Corneal Fluorescein Stain - Total, Change From Baseline-2.53 ± 0.527-0.23 ± 0.753
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.0143
SecondaryCorneal Fluorescein Stain - Total, Change From Baseline

Change in score from Baseline for worse eye. Fluorescein staining score in Total comprise Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.

Time frame:
6 weeks
Reported as:
Least squares mean · score on a scale
Corneal Fluorescein Stain - Total, Change From Baseline
score on a scalePro-ocular™Placebo
Corneal Fluorescein Stain - Total, Change From Baseline-3.28 ± 0.537-1.35 ± 0.753
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.0398
SecondaryCorneal Fluorescein Stain - Total, Change From Baseline

Change in score from Baseline for worse eye. Fluorescein staining score in Total comprise Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.

Time frame:
10 weeks
Reported as:
Least squares mean · score on a scale
Corneal Fluorescein Stain - Total, Change From Baseline
score on a scalePro-ocular™Placebo
Corneal Fluorescein Stain - Total, Change From Baseline-3.97 ± 0.537-1.54 ± 0.763
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = -3.97
SecondaryBlurred Vision, Change From Baseline

Change in score from Baseline for worse eye. Score measured from visual analog scale 0-10, higher values represent worse outcomes. Blurred vision symptom is reported by participant.

Time frame:
2 weeks
Reported as:
Least squares mean · score on a scale
Blurred Vision, Change From Baseline
score on a scalePro-ocular™Placebo
Blurred Vision, Change From Baseline-2.07 ± 0.4000.40 ± 0.568
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.0005
SecondaryBlurred Vision, Change From Baseline

Change in score from Baseline for worse eye. Score measured from visual analog scale 0-10, higher values represent worse outcomes. Blurred vision symptom is reported by participant.

Time frame:
6 weeks
Reported as:
Least squares mean · score on a scale
Blurred Vision, Change From Baseline
score on a scalePro-ocular™Placebo
Blurred Vision, Change From Baseline-2.09 ± 0.4040.39 ± 0.568
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.0005
SecondaryBlurred Vision, Change From Baseline

Change in score from Baseline for worse eye. Score measured from visual analog scale 0-10, higher values represent worse outcomes. Blurred vision symptom is reported by participant.

Time frame:
10 weeks
Reported as:
Least squares mean · score on a scale
Blurred Vision, Change From Baseline
score on a scalePro-ocular™Placebo
Blurred Vision, Change From Baseline-2.23 ± 0.404-0.31 ± 0.568
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.0067
SecondaryPhotophobia, Change From Baseline

Change in score from Baseline for worse eye. Score is recorded on a visual analog scale 0-10, higher values represent worse outcomes. Sensitivity to light symptom is reported by participant.

Time frame:
2 weeks
Reported as:
Least squares mean · score on a scale
Photophobia, Change From Baseline
score on a scalePro-ocular™Placebo
Photophobia, Change From Baseline-1.23 ± 0.4320.18 ± 0.695
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.0636
SecondaryPhotophobia, Change From Baseline

Change in score from Baseline for worse eye. Score is recorded on a visual analog scale 0-10, higher values represent worse outcomes. Sensitivity to light symptom is reported by participant.

Time frame:
6 weeks
Reported as:
Least squares mean · score on a scale
Photophobia, Change From Baseline
score on a scalePro-ocular™Placebo
Photophobia, Change From Baseline-1.68 ± 0.4370.62 ± 0.613
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.0028
SecondaryPhotophobia, Change From Baseline

Change in score from Baseline for worse eye. Score is recorded on a visual analog scale 0-10, higher values represent worse outcomes. Sensitivity to light symptom is reported by participant.

Time frame:
10 weeks
Reported as:
Least squares mean · score on a scale
Photophobia, Change From Baseline
score on a scalePro-ocular™Placebo
Photophobia, Change From Baseline-1.82 ± 0.4370.01 ± 0.612
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.0067
SecondaryLid Edema, Change From Baseline

Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid edema is viewed by slit lamp without stain.

Time frame:
2 weeks
Reported as:
Least squares mean · score on a scale
Lid Edema, Change From Baseline
score on a scalePro-ocular™Placebo
Lid Edema, Change From Baseline-1.73 ± 0.206-0.80 ± 0.293
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.0105
SecondaryLid Edema, Change From Baseline

Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid edema is viewed by slit lamp without stain.

Time frame:
6 weeks
Reported as:
Least squares mean · score on a scale
Lid Edema, Change From Baseline
score on a scalePro-ocular™Placebo
Lid Edema, Change From Baseline-2.21 ± 0.210-0.98 ± 0.293
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.0010
SecondaryLid Edema, Change From Baseline

Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid edema is viewed by slit lamp without stain.

Time frame:
10 weeks
Reported as:
Least squares mean · score on a scale
Lid Edema, Change From Baseline
score on a scalePro-ocular™Placebo
Lid Edema, Change From Baseline-1.72 ± 0.210-0.83 ± 0.293
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.0155
SecondaryLid Erythema, Change From Baseline

Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid erythema is viewed by slit lamp without stain.

Time frame:
2 weeks
Reported as:
Least squares mean · score on a scale
Lid Erythema, Change From Baseline
score on a scalePro-ocular™Placebo
Lid Erythema, Change From Baseline-1.08 ± 0.224-0.13 ± 0.317
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.0160
SecondaryLid Erythema, Change From Baseline

Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid erythema is viewed by slit lamp without stain.

Time frame:
6 weeks
Reported as:
Least squares mean · score on a scale
Lid Erythema, Change From Baseline
score on a scalePro-ocular™Placebo
Lid Erythema, Change From Baseline-1.53 ± 0.229-0.58 ± 0.317
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.0117
SecondaryLid Erythema, Change From Baseline

Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid erythema is viewed by slit lamp without stain.

Time frame:
10 weeks
Reported as:
Least squares mean · score on a scale
Lid Erythema, Change From Baseline
score on a scalePro-ocular™Placebo
Lid Erythema, Change From Baseline-1.42 ± 0.229-1.27 ± 0.354
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.4649
SecondaryLid Margin Ulceration, Change From Baseline

Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid margin ulceration is viewed by slit lamp without stain.

Time frame:
2 weeks
Reported as:
Least squares mean · score on a scale
Lid Margin Ulceration, Change From Baseline
score on a scalePro-ocular™Placebo
Lid Margin Ulceration, Change From Baseline-1.14 ± 0.240-0.01 ± 0.341
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.0082
SecondaryLid Margin Ulceration, Change From Baseline

Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid margin ulceration is viewed by slit lamp without stain.

Time frame:
6 weeks
Reported as:
Least squares mean · score on a scale
Lid Margin Ulceration, Change From Baseline
score on a scalePro-ocular™Placebo
Lid Margin Ulceration, Change From Baseline-1.57 ± 0.245-0.59 ± 0.341
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.0225
SecondaryLid Margin Ulceration, Change From Baseline

Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Lid margin ulceration is viewed by slit lamp without stain.

Time frame:
10 weeks
Reported as:
Least squares mean · score on a scale
Lid Margin Ulceration, Change From Baseline
score on a scalePro-ocular™Placebo
Lid Margin Ulceration, Change From Baseline-1.85 ± 0.245-1.27 ± 0.354
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.1822
SecondaryConjunctival Hyperemia, Change From Baseline

Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Conjunctival hyperemia is viewed by slit lamp without stain.

Time frame:
2 weeks
Reported as:
Least squares mean · score on a scale
Conjunctival Hyperemia, Change From Baseline
score on a scalePro-ocular™Placebo
Conjunctival Hyperemia, Change From Baseline-1.50 ± 0.235-0.70 ± 0.333
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.0515
SecondaryConjunctival Hyperemia, Change From Baseline

Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Conjunctival hyperemia is viewed by slit lamp without stain.

Time frame:
6 weeks
Reported as:
Least squares mean · score on a scale
Conjunctival Hyperemia, Change From Baseline
score on a scalePro-ocular™Placebo
Conjunctival Hyperemia, Change From Baseline-1.75 ± 0.240-0.92 ± 0.333
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.044
SecondaryConjunctival Hyperemia, Change From Baseline

Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Conjunctival hyperemia is viewed by slit lamp without stain.

Time frame:
10 weeks
Reported as:
Least squares mean · score on a scale
Conjunctival Hyperemia, Change From Baseline
score on a scalePro-ocular™Placebo
Conjunctival Hyperemia, Change From Baseline-1.72 ± 0.240-0.99 ± 0.333
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.083
SecondaryDryness, Change From Baseline

Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Dryness symptom is reported by participant.

Time frame:
2 weeks
Reported as:
Least squares mean · score on a scale
Dryness, Change From Baseline
score on a scalePro-ocular™Placebo
Dryness, Change From Baseline-2.48 ± 0.391-2.23 ± 0.554
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.7147
SecondaryDryness, Change From Baseline

Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Dryness symptom is reported by participant.

Time frame:
6 weeks
Reported as:
Least squares mean · score on a scale
Dryness, Change From Baseline
score on a scalePro-ocular™Placebo
Dryness, Change From Baseline-2.91 ± 0.398-2.76 ± 0.554
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.8251
SecondaryDryness, Change From Baseline

Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Dryness symptom is reported by participant.

Time frame:
10 weeks
Reported as:
Least squares mean · score on a scale
Dryness, Change From Baseline
score on a scalePro-ocular™Placebo
Dryness, Change From Baseline-3.67 ± 0.398-2.28 ± 0.554
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.0435
SecondaryOcular Pain, Change From Baseline

Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Ocular pain symptom is reported by participant.

Time frame:
2 weeks
Reported as:
Least squares mean · score on a scale
Ocular Pain, Change From Baseline
score on a scalePro-ocular™Placebo
Ocular Pain, Change From Baseline-1.64 ± 0.310-0.29 ± 0.439
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.0130
SecondaryOcular Pain, Change From Baseline

Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Ocular pain symptom is reported by participant.

Time frame:
6 weeks
Reported as:
Least squares mean · score on a scale
Ocular Pain, Change From Baseline
score on a scalePro-ocular™Placebo
Ocular Pain, Change From Baseline-1.53 ± 0.316-0.99 ± 0.439
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.3205
SecondaryOcular Pain, Change From Baseline

Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Ocular pain symptom is reported by participant.

Time frame:
10 weeks
Reported as:
Least squares mean · score on a scale
Ocular Pain, Change From Baseline
score on a scalePro-ocular™Placebo
Ocular Pain, Change From Baseline-1.86 ± 0.316-1.06 ± 0.499
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.1401
SecondaryAirflow Sensitivity, Change From Baseline

Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Airflow sensitivity symptom is reported by participant.

Time frame:
2 weeks
Reported as:
Least squares mean · score on a scale
Airflow Sensitivity, Change From Baseline
score on a scalePro-ocular™Placebo
Airflow Sensitivity, Change From Baseline-1.93 ± 0.401-0.68 ± 0.567
Statistical analysis
  • Pro-ocular™ vs Placebo · ANCOVA · p = 0.0098
SecondaryAirflow Sensitivity, Change From Baseline

Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Airflow sensitivity symptom is reported by participant.

Time frame:
6 weeks
Reported as:
Least squares mean · score on a scale
Airflow Sensitivity, Change From Baseline
score on a scalePro-ocular™Placebo
Airflow Sensitivity, Change From Baseline-1.69 ± 0.407-0.53 ± 0.583
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.1032
SecondaryAirflow Sensitivity, Change From Baseline

Change in score from Baseline for worse eye. Score on a visual analog scale 0-10, higher values represent worse outcomes. Airflow sensitivity symptom is reported by participant.

Time frame:
10 weeks
Reported as:
Least squares mean · score on a scale
Airflow Sensitivity, Change From Baseline
score on a scalePro-ocular™Placebo
Airflow Sensitivity, Change From Baseline-1.76 ± 0.407-0.31 ± 0.567
Statistical analysis
  • Pro-ocular™ vs Placebo · Mixed Models Analysis · p = 0.0389
Other pre-specifiedModified SANDE Questionnaire - Frequency

Score on a visual analog scale 0-100, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?

Time frame:
1 year
Reported as:
Least squares mean · units on a scale
Modified SANDE Questionnaire - Frequency
units on a scalePro-ocular + Placebo BaselinePro-ocular + Placebo at 1 Year
Modified SANDE Questionnaire - Frequency82.03 ± 11.71933.04 ± 27.517
Statistical analysis
  • Pro-ocular + Placebo Baseline vs Pro-ocular + Placebo at 1 Year · t-test, 2 sided · p = <0.00001
Other pre-specifiedModified SANDE Questionnaire - Frequency

Score on a visual analog scale 0-100, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. How often do eyes feel dry and/or irritated?

Time frame:
2 years
Reported as:
Least squares mean · units on a scale
Modified SANDE Questionnaire - Frequency
units on a scalePro-ocular + Placebo BaselinePro-ocular + Placebo at 2 Years
Modified SANDE Questionnaire - Frequency82.03 ± 11.71935.29 ± 27.637
Statistical analysis
  • Pro-ocular + Placebo Baseline vs Pro-ocular + Placebo at 2 Years · t-test, 2 sided · p = <0.00001
Other pre-specifiedModified SANDE Questionnaire - Global

Score on a visual analog scale 0-100, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. Global score is square root of how often do eyes feel dry and/or irritated x how severe are your symptoms of dryness and/or irritation?

Time frame:
1 year
Reported as:
Least squares mean · units on a scale
Modified SANDE Questionnaire - Global
units on a scalePro-ocular + Placebo BaselinePro-ocular + Placebo at 1 Year
Modified SANDE Questionnaire - Global74.39 ± 16.62032.63 ± 24.407
Statistical analysis
  • Pro-ocular + Placebo Baseline vs Pro-ocular + Placebo at 1 Year · t-test, 2 sided · p = <0.00001
Other pre-specifiedModified SANDE Questionnaire - Global

Score on a visual analog scale 0-100, higher values represent worse outcomes. Symptom Assessment iN Dry Eye Questionnaire. Global score is square root of how often do eyes feel dry and/or irritated x how severe are your symptoms of dryness and/or irritation?

Time frame:
2 years
Reported as:
Least squares mean · units on a scale
Modified SANDE Questionnaire - Global
units on a scalePro-ocular + Placebo BaselinePro-ocular + Placebo at 2 Years
Modified SANDE Questionnaire - Global74.39 ± 16.62031.04 ± 22.037
Statistical analysis
  • Pro-ocular + Placebo Baseline vs Pro-ocular + Placebo at 2 Years · t-test, 2 sided · p = <0.00001
Other pre-specifiedCorneal Fluorescein Stain - Central

Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.

Time frame:
1 year
Reported as:
Least squares mean · units on a scale
Corneal Fluorescein Stain - Central
units on a scalePro-ocular + Placebo BaselinePro-ocular + Placebo at 1 Year
Corneal Fluorescein Stain - Central3.57 ± 2.7791.12 ± 1.522
Statistical analysis
  • Pro-ocular + Placebo Baseline vs Pro-ocular + Placebo at 1 Year · t-test, 2 sided · p = 0.0002
Other pre-specifiedCorneal Fluorescein Stain - Central

Fluorescein staining score in central corneal region recorded on visual analog scale 0-10, higher values represent worse outcomes.

Time frame:
2 years
Reported as:
Least squares mean · units on a scale
Corneal Fluorescein Stain - Central
units on a scalePro-ocular + Placebo BaselinePro-ocular + Placebo at 2 Years
Corneal Fluorescein Stain - Central3.57 ± 2.7790.77 ± 1.224
Statistical analysis
  • Pro-ocular + Placebo Baseline vs Pro-ocular + Placebo at 2 Years · t-test, 2 sided · p = 0.0001
Other pre-specifiedCorneal Fluorescein Stain - Total

Fluorescein staining score Total for worse eye. Total comprise Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.

Time frame:
1 year
Reported as:
Least squares mean · units on a scale
Corneal Fluorescein Stain - Total
units on a scalePro-ocular + Placebo BaselinePro-ocular + Placebo at 1 Year
Corneal Fluorescein Stain - Total11.52 ± 7.1373.65 ± 3.289
Statistical analysis
  • Pro-ocular + Placebo Baseline vs Pro-ocular + Placebo at 1 Year · t-test, 2 sided · p = <0.00001
Other pre-specifiedCorneal Fluorescein Stain - Total

Fluorescein staining score Total for worse eye. Total comprises Central, Inferior and Superior regions, sum score 0-30, higher values represent worse outcomes.

Time frame:
2 years
Reported as:
Least squares mean · units on a scale
Corneal Fluorescein Stain - Total
units on a scalePro-ocular + Placebo BaselinePro-ocular + Placebo at 2 Years
Corneal Fluorescein Stain - Total11.52 ± 7.1372.81 ± 3.699
Statistical analysis
  • Pro-ocular + Placebo Baseline vs Pro-ocular + Placebo at 2 Years · t-test, 2 sided · p = <0.00001
Other pre-specifiedBlurred Vision

Score for worse eye, recorded on a visual analog scale 0-10, higher values represent worse outcomes. Blurred vision symptom is reported by participant.

Time frame:
1 year
Reported as:
Least squares mean · units on a scale
Blurred Vision
units on a scalePro-ocular + Placebo BaselinePro-ocular + Placebo at 1 Year
Blurred Vision7.59 ± 2.6102.20 ± 2.582
Statistical analysis
  • Pro-ocular + Placebo Baseline vs Pro-ocular + Placebo at 1 Year · t-test, 2 sided · p = <0.00001
Other pre-specifiedBlurred Vision

Score for worse eye, recorded on a visual analog scale 0-10, higher values represent worse outcomes. Blurred vision symptom is reported by participant.

Time frame:
2 years
Reported as:
Least squares mean · units on a scale
Blurred Vision
units on a scalePro-ocular + Placebo BaselinePro-ocular + Placebo at 2 Years
Blurred Vision7.59 ± 2.6101.66 ± 2.768
Statistical analysis
  • Pro-ocular + Placebo Baseline vs Pro-ocular + Placebo at 2 Years · t-test, 2 sided · p = <0.00001
Other pre-specifiedLid Edema

Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Lid edema is scored by ophthalmologist using slit lamp biomicroscopy without staining.

Time frame:
1 year
Reported as:
Least squares mean · score on a scale
Lid Edema
score on a scalePro-ocular + Placebo BaselinePro-ocular + Placebo at 1 Year
Lid Edema3.74 ± 2.7850.72 ± 0.995
Statistical analysis
  • Pro-ocular + Placebo Baseline vs Pro-ocular + Placebo at 1 Year · t-test, 2 sided · p = <0.00001
Other pre-specifiedLid Edema

Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Lid edema is scored by ophthalmologist using slit lamp biomicroscopy without staining.

Time frame:
2 years
Reported as:
Least squares mean · score on a scale
Lid Edema
score on a scalePro-ocular + Placebo BaselinePro-ocular + Placebo at 2 Years
Lid Edema3.74 ± 2.7850.71 ± 1.085
Statistical analysis
  • Pro-ocular + Placebo Baseline vs Pro-ocular + Placebo at 2 Years · t-test, 2 sided · p = <0.00001
Other pre-specifiedLid Erythema

Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Lid erythema is scored by ophthalmologist using slit lamp biomicroscopy without staining.

Time frame:
1 year
Reported as:
Least squares mean · score on a scale
Lid Erythema
score on a scalePro-ocular + Placebo BaselinePro-ocular + Placebo at 1 Year
Lid Erythema3.92 ± 2.7381.17 ± 1.457
Statistical analysis
  • Pro-ocular + Placebo Baseline vs Pro-ocular + Placebo at 1 Year · t-test, 2 sided · p = 0.0001
Other pre-specifiedLid Erythema

Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Lid erythema is scored by ophthalmologist using slit lamp biomicroscopy without staining.

Time frame:
2 years
Reported as:
Least squares mean · score on a scale
Lid Erythema
score on a scalePro-ocular + Placebo BaselinePro-ocular + Placebo at 2 Years
Lid Erythema3.92 ± 2.7380.80 ± 1.144
Statistical analysis
  • Pro-ocular + Placebo Baseline vs Pro-ocular + Placebo at 2 Years · t-test, 2 sided · p = <0.00001
Other pre-specifiedLid Ulceration

Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Lid ulceration is scored by ophthalmologist using slit lamp biomicroscopy without staining.

Time frame:
1 year
Reported as:
Least squares mean · score on a scale
Lid Ulceration
score on a scalePro-ocular + Placebo BaselinePro-ocular + Placebo at 1 Year
Lid Ulceration4.07 ± 2.2891.14 ± 1.143
Statistical analysis
  • Pro-ocular + Placebo Baseline vs Pro-ocular + Placebo at 1 Year · t-test, 2 sided · p = <0.00001
Other pre-specifiedLid Ulceration

Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Lid erythema is scored by ophthalmologist using slit lamp biomicroscopy without staining.

Time frame:
2 years
Reported as:
Least squares mean · score on a scale
Lid Ulceration
score on a scalePro-ocular + Placebo BaselinePro-ocular + Placebo at 2 Years
Lid Ulceration4.07 ± 2.2890.42 ± 0.628
Statistical analysis
  • Pro-ocular + Placebo Baseline vs Pro-ocular + Placebo at 2 Years · t-test, 2 sided · p = <0.00001
Other pre-specifiedConjunctival Hyperemia

Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Conjunctival hyperemia is scored by ophthalmologist using slit lamp biomicroscopy without staining.

Time frame:
1 year
Reported as:
Least squares mean · score on a scale
Conjunctival Hyperemia
score on a scalePro-ocular + Placebo BaselinePro-ocular + Placebo at 1 Year
Conjunctival Hyperemia3.67 ± 2.3540.80 ± 1.238
Statistical analysis
  • Pro-ocular + Placebo Baseline vs Pro-ocular + Placebo at 1 Year · t-test, 2 sided · p = <0.00001
Other pre-specifiedConjunctival Hyperemia

Score for worse eye on a visual analog scale 0-10, higher values represent worse outcomes. Conjunctival hyperemia is scored by ophthalmologist using slit lamp biomicroscopy without staining.

Time frame:
2 years
Reported as:
Least squares mean · score on a scale
Conjunctival Hyperemia
score on a scalePro-ocular + Placebo BaselinePro-ocular + Placebo at 2 Years
Conjunctival Hyperemia3.67 ± 2.3540.46 ± 0.886
Statistical analysis
  • Pro-ocular + Placebo Baseline vs Pro-ocular + Placebo at 2 Years · t-test, 2 sided · p = <0.00001

Adverse events

Collected over 2 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Pro-ocular™ for 2 Years1/22 (4.5%)8/22 (36.4%)21/22 (95.5%)
Pro-ocular™ for 10-week Masked Period Only0/22 (0%)0/22 (0%)17/22 (77.3%)
Placebo+Active for 2 Years Total1/11 (9.1%)7/11 (63.6%)11/11 (100%)
Placebo for 10-week Masked Period Ony0/11 (0%)2/11 (18.2%)8/11 (72.7%)
Most frequent serious events
Showing 10 of 25
Most frequent serious events
EventPro-ocular™ for 2 YearsPro-ocular™ for 10-week Masked Period OnlyPlacebo+Active for 2 Years TotalPlacebo for 10-week Masked Period Ony
SepsisInfections and infestations0/220/221/112/11
Acute lymphocytic leukaemia recurrentBlood and lymphatic system disorders1/220/221/110/11
Endocrine neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/220/221/110/11
Rib fractureMusculoskeletal and connective tissue disorders0/220/221/110/11
PneumoniaRespiratory, thoracic and mediastinal disorders0/220/221/110/11
Respiratory failureRespiratory, thoracic and mediastinal disorders0/220/221/110/11
Cardiopulmonary failureCardiac disorders0/220/221/110/11
Corneal perforationEye disorders0/220/221/111/11
Corneal thinningEye disorders0/220/221/110/11
Corneal epithelium defectEye disorders0/22—1/110/11
Most frequent other events
Showing 10 of 15
Most frequent other events
EventPro-ocular™ for 2 YearsPro-ocular™ for 10-week Masked Period OnlyPlacebo+Active for 2 Years TotalPlacebo for 10-week Masked Period Ony
HeadacheNervous system disorders6/226/221/111/11
RhinorrheaRespiratory, thoracic and mediastinal disorders6/226/220/110/11
Ocular hyperaemiaEye disorders0/220/222/113/11
Eye painEye disorders2/222/222/112/11
CoughRespiratory, thoracic and mediastinal disorders1/221/222/111/11
Conjunctival haemorrhageEye disorders2/221/220/110/11
Corneal abrasionEye disorders2/221/221/111/11
Eye pruritusEye disorders2/222/221/110/11
Vitreous floatersEye disorders2/221/220/110/11
NauseaGastrointestinal disorders2/222/221/111/11

Baseline characteristics

Age, Continuous
Age, Continuous(years)Pro-ocular™PlaceboTotal
Mean61.9 ± 12.4858.9 ± 13.2060.9 ± 12.60
Sex: Female, Male
Sex: Female, Male(Participants)Pro-ocular™PlaceboTotal
Female9312
Male13821
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Pro-ocular™PlaceboTotal
Hispanic or Latino000
Not Hispanic or Latino221133
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Pro-ocular™PlaceboTotal
American Indian or Alaska Native000
Asian112
Native Hawaiian or Other Pacific Islander000
Black or African American000
White21930
More than one race000
Unknown or Not Reported011
Region of Enrollment
Region of Enrollment(participants)Pro-ocular™PlaceboTotal
United States221133
Ocular Graft versus Host Diagnosis
Ocular Graft versus Host Diagnosis(Participants)Pro-ocular™PlaceboTotal
Count of participants221133
Time of HSCT to oGvHD Diagnosis
Time of HSCT to oGvHD Diagnosis(months)Pro-ocular™PlaceboTotal
Mean27.5 ± 22.540.0 ± 49.931.6 ± 33.8
NIH Eye Score
NIH Eye Score(Participants)Pro-ocular™PlaceboTotal
Score 0-1000
Score 213518
Score 39615

5 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Massachusetts Eye and Ear Longwood
    Boston, Massachusetts 02115, United States
09

References and documents

Publications

  • Luo ZK, Domenech-Estarellas EA, Han A, Lee D, Khatri R, Wahl JL, Cutler C, Armand P, Antin JH, Koreth J, Gooptu M, Alyea EP, Soiffer RJ, Ho VT. Efficacy and Safety of 1% Progesterone Gel to the Forehead for Ocular Chronic Graft-versus-Host Disease. Transplant Cell Ther. 2021 May;27(5):433.e1-433.e8. doi: 10.1016/j.jtct.2021.02.008. Epub 2021 Feb 14. PubMed 33942724 ↗

Study documents

  • Study protocol · Mar 17, 2020
  • Statistical analysis plan · Sep 18, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Data may be shared with other investigators.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03990051
Lead sponsor
Glia, LLC
Collaborators
ORA, Inc.
Responsible party
Sponsor
First posted
Jun 18, 2019
Start date
Oct 17, 2019
Primary completion
Oct 31, 2021
Completion
Nov 19, 2021
Results posted
May 6, 2025
Last update
May 6, 2025

Study contacts

Zhonghui K Luo, MD, PhD
principal investigator · Massachusetts Eye and Ear, Longwood

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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