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Status unknownNCT04884217Updated May 14, 2021

Treatment of Dry Eye Disease Using Pro-ocular™ - A Proof of Concept, Safety, and Efficacy Study

A Phase 2 interventional study of Pro-ocular™ Topical Gel and Placebo Topical Gel in Dry Eye Syndrome and Keratoconjunctivitis Sicca, sponsored by PharmaDax Inc.. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-05-14.

Primary conditionKeratoconjunctivitis SiccaRegistry: Dry Eye SyndromesReclassifiedWhy we changed it
Registry
Dry Eye Syndromes — the first condition term the registry derived for this study.
ClinicalTrials.gg
Keratoconjunctivitis Sicca
Why
  1. The study's listed conditions name Keratoconjunctivitis Sicca, a narrower term within Dry Eye Syndromes.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by PharmaDax Inc. · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2021), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

To evaluate the safety and efficacy of 1% Pro-ocular topical gel administered twice daily for 12 weeks in treatment of Dry Eye Disease

Read the detailed description

Pro-ocular™ 1% topical gel his demonstrated efficacy in rapidly reducing or eliminating dry eye symptoms, and after multiple doses, the signs and symptoms of ocular surface disease including dry eye disease.

Study DE-2 is single center, randomized, double-masked, placebo-controlled, parallel-group study designed to evaluate the safety and efficacy of 1% Pro-ocular topical gel administered twice daily for 12 weeks for treatment of Dry Eye Disease. The approximately 80 subjects will be randomized 1:1, active drug:placebo.

02

Conditions studied

  • Dry Eye Syndrome
  • Keratoconjunctivitis Sicca

Browse trials for

Keywords

  • Dry Eye
  • Dry Eye Disease
  • Evaporative Dry Eye
  • Evaporative Dry Eye Disease
  • Keratoconjuncitivitis Sicca
  • Sjogren's Sydrome
03

In context

Keratoconjunctivitis Sicca Reclassified

85 studies on the registry are indexed under Keratoconjunctivitis Sicca; 1 is open to participants now.

This study's planned enrollment of 80 is close to the median of 82 across 75 interventional studies indexed under Keratoconjunctivitis Sicca.

Browse Keratoconjunctivitis Sicca studies →

Lead sponsor

This is the only study on the registry with PharmaDax Inc. as lead sponsor.

Compared within Keratoconjunctivitis Sicca, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Dry Eye Syndromes. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female of any race, at least 20 years of age at Visit 1 Screening.
  2. Has a subject reported history (including physician diagnosis) of dry eye disease in both eyes for at least 3 months prior to Visit 1.
  3. Has SANDE score ≥50 in either frequency or severity of symptoms of dryness and/or irritation at Visit 1.

  4. Have all of the following in the same eye at Visit 1:

    1. Fluorescein Tear Break-Up Time of ≤5 seconds.
    2. Corneal fluorescein staining score of moderate or more in any field (inferior, superior or central).
    3. Report a severity score of moderate or more on ocular dryness and at least one of the other symptoms on the GLIA Ocular Surface Disease Symptoms Questionnaire.
  5. Has provided written .
  6. Be able and willing to follow oral and written instructions, including participation in all study assessments and visits.

Exclusion criteria

Exclusion Criteria:

  1. 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 corneal opacities and scars, dystrophies, epithelial scarring, infections, history of blood clots, etc.
  2. Has infections, or inflammatory skin lesion in or around the dosing area.
  3. Best corrected visual acuity baseline \<20/200.
  4. Has a condition or history that, in the opinion of the investigator, may interfere significantly with the subject's participation in the study.
  5. Wear contact lens within 7 days prior to Visit 1.
  6. Anticipate change of vision correction or anticipate any ocular procedures during study period.
  7. A woman who is pregnant or testing positive in the blood pregnancy test at screening, nursing an infant, or planning a pregnancy.
  8. Has a known adverse reaction and/or sensitivity to the study drug or its components.
  9. Use of topical ocular cyclosporine (e.g. Restasis®), lifitegrast (Xiidra®), diquafosol (Diquas®), eye gels, eye ointments, any administration route of , anti-histamines, antipsychotics, antidepressants and NSAIDs within 30 days prior to Visit 1.
  10. Routine use (more than once a week) of a chlorinated swimming pool during study period.
  11. Unwilling or unable to cease using the following medications during the study period (from Visit 1 to Visit 6): Topical ocular cyclosporine (e.g. Restasis®), lifitegrast (Xiidra®), diquafosol (Diquas®), eye gels, eye ointments, any administration route of steroids, anti-histamines, antipsychotics, antidepressants and NSAIDs..
  12. Unwilling to cease the use of sunscreen and face scrubs on the forehead or eye area during study period.
  13. Smoke within 3 months prior to Visit 1.
  14. Ongoing glaucoma treatment within 30 days prior to Visit 1 and during study period.
  15. Currently enrolled in an drug or device study within 30 days prior to Visit 1 and during study period.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

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

Study arms

  • Active comparator
    Pro-ocular™

    Pro-ocular™ Topical Gel

    Drug: Pro-ocular™ Topical Gel

  • Placebo comparator
    Placebo

    Placebo Topical Gel

    Drug: Placebo Topical Gel

Interventions

  • DrugPro-ocular™ Topical Gel

    Pro-ocular™ Topical Gel 1% is applied dermally to the forehead twice-daily

    Also known as: PG101

  • DrugPlacebo Topical Gel

    Placebo is a toopical gel without active ingredient applied dermally to the forehead twice-daily

06

What researchers measure

Primary outcomes

  1. Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Frequency score

    Change from baseline in SANDE symptoms frequency score (0-100 worst)

    Time frame: 2 weeks

  2. Change in corneal (central) fluorescein staining score

    Change from baseline in score on a visual analog scale (0-10 worst)

    Time frame: 4 weeks

Secondary outcomes

  1. Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Global score

    Change from baseline in SANDE symptoms global score (0-100 worst)

    Time frame: 2 weeks

  2. Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Global score

    Change from baseline in SANDE symptoms global score (0-100 worst)

    Time frame: 4 weeks

  3. Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Global score

    Change from baseline in SANDE symptoms global score (0-100 worst)

    Time frame: 8 weeks

  4. Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Global score

    Change from baseline in SANDE symptoms global score (0-100 worst)

    Time frame: 12 weeks

  5. Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Frequency score

    Change from baseline in SANDE symptoms frequency score (0-100 worst)

    Time frame: 4 weeks

  6. Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Frequency score

    Change from baseline in SANDE symptoms frequency score (0-100 worst)

    Time frame: 8 weeks

  7. Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Frequency score

    Change from baseline in SANDE symptoms frequency score (0-100 worst)

    Time frame: 12 weeks

  8. Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Severity score

    Change from baseline in SANDE symptoms severity score (0-100 worst)

    Time frame: 2 weeks

  9. Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Severity score

    Change from baseline in SANDE symptoms severity score (0-100 worst)

    Time frame: 4 weeks

  10. Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Severity score

    Change from baseline in SANDE symptoms severity score (0-100 worst)

    Time frame: 8 weeks

  11. Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Severity score

    Change from baseline in SANDE symptoms severity score (0-100 worst)

    Time frame: 12 weeks

  12. Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score

    Change from baseline in GLIA OSDSQ ocular discomfort score (0-10 worst)

    Time frame: 1 hour

  13. Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score

    Change from baseline in GLIA OSDSQ ocular discomfort score (0-10 worst)

    Time frame: 2 weeks

  14. Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score

    Change from baseline in GLIA OSDSQ ocular discomfort score (0-10 worst)

    Time frame: 4 weeks

  15. Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score

    Change from baseline in GLIA OSDSQ ocular discomfort score (0-10 worst)

    Time frame: 8 weeks

  16. Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score

    Change from baseline in GLIA OSDSQ ocular discomfort score (0-10 worst)

    Time frame: 12 weeks

  17. Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores

    Change from baseline in GLIA OSDSQ sum of scores (highest worst)

    Time frame: 1 hour

  18. Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores

    Change from baseline in GLIA OSDSQ sum of scores (highest worst)

    Time frame: 2 weeks

  19. Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores

    Change from baseline in GLIA OSDSQ sum of scores (highest worst)

    Time frame: 4 weeks

  20. Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores

    Change from baseline in GLIA OSDSQ sum of scores (highest worst)

    Time frame: 8 weeks

  21. Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores

    Change from baseline in GLIA OSDSQ sum of scores (highest worst)

    Time frame: 12 weeks

  22. Change in Tear Film Grading by TearScan examination

    Change from baseline in tear film grade (0-3 best)

    Time frame: 1 hour

  23. Change in Tear Film Grading by TearScan examination

    Change from baseline in tear film grade (0-3 best)

    Time frame: 2 weeks

  24. Change in Tear Film Grading by TearScan examination

    Change from baseline in tear film grade (0-3 best)

    Time frame: 4 weeks

  25. Change in Tear Film Grading by TearScan examination

    Change from baseline in tear film grade (0-3 best)

    Time frame: 8 weeks

  26. Change in Tear Film Grading by TearScan examination

    Change from baseline in tear film grade (0-3 best)

    Time frame: 12 weeks

  27. Change in Meibography score by Keratograph®

    Change from baseline using Grades 0 to 3 (0 no loss to 3 \>2/3 loss)

    Time frame: 12 weeks

  28. Change in Tear Meniscus Height (TMH) by Keratograph®

    Change from baseline in mm TMH (higher is better)

    Time frame: 1 hour

  29. Change in Tear Meniscus Height (TMH) by Keratograph®

    Change from baseline in mm TMH (higher is better)

    Time frame: 4 weeks

  30. Change in Tear Meniscus Height (TMH) by Keratograph®

    Change from baseline in mm TMH (higher is better)

    Time frame: 8 weeks

  31. Change in Tear Meniscus Height (TMH) by Keratograph®

    Change from baseline in mm TMH (higher is better)

    Time frame: 12 weeks

  32. Change in Non-Invasive Keratograph® Tear Break-Up Time (NIKBUT)

    Change from baseline in NIKBUT in seconds (longer is better)

    Time frame: 1 hour

  33. Change in Non-Invasive Keratograph® Tear Break-Up Time (NIKBUT)

    Change from baseline in NIKBUT in seconds (longer is better)

    Time frame: 4 weeks

  34. Change in Non-Invasive Keratograph® Tear Break-Up Time (NIKBUT)

    Change from baseline in NIKBUT in seconds (longer is better)

    Time frame: 8 weeks

  35. Change in Non-Invasive Keratograph® Tear Break-Up Time (NIKBUT)

    Change from baseline in NIKBUT in seconds (longer is better)

    Time frame: 12 weeks

  36. Change in Bulbar redness score by Keratograph®

    Change from baseline in Bulbar redness score (highest is worst)

    Time frame: 1 hour

  37. Change in Bulbar redness score by Keratograph®

    Change from baseline in Bulbar redness score (highest is worst)

    Time frame: 4 weeks

  38. Change in Bulbar redness score by Keratograph®

    Change from baseline in Bulbar redness score (highest is worst)

    Time frame: 8 weeks

  39. Change in Bulbar redness score by Keratograph®

    Change from baseline in Bulbar redness score (highest is worst)

    Time frame: 12 weeks

  40. Change in tear film osmolarity by TearLab™ osmolarity system

    Change from baseline in mOsms/L (higher value is worse)

    Time frame: 1 hour

  41. Change in tear film osmolarity by TearLab™ osmolarity system

    Change from baseline in mOsms/L (higher value is less sensitive)

    Time frame: 2 weeks

  42. Change in corneal sensitivity using Cochet-Bonnet esthesiometer

    Change from baseline in mm Hg (higher is less sensitive)

    Time frame: 1 hour

  43. Change in corneal sensitivity using Cochet-Bonnet esthesiometer

    Change from baseline in mm Hg (higher is less sensitive)

    Time frame: 2 weeks

  44. Change in corneal sensitivity using Cochet-Bonnet esthesiometer

    Change from baseline in mm Hg (higher is less sensitive)

    Time frame: 4 weeks

  45. Change in corneal sensitivity using Cochet-Bonnet esthesiometer

    Change from baseline in mm Hg (higher is less sensitive)

    Time frame: 8 weeks

  46. Change in corneal sensitivity using Cochet-Bonnet esthesiometer

    Change from baseline in mm Hg (higher is less sensitive)

    Time frame: 12 weeks

  47. Change in Fluorescein Tear Break-Up Time (FBUT)

    Change from baseline in FBUT in seconds (longer is better)

    Time frame: 1 hour

  48. Change in Fluorescein Tear Break-Up Time (FBUT)

    Change from baseline in FBUT in seconds (longer is better)

    Time frame: 4 weeks

  49. Change in Fluorescein Tear Break-Up Time (FBUT)

    Change from baseline in FBUT in seconds (longer is better)

    Time frame: 8 weeks

  50. Change in Fluorescein Tear Break-Up Time (FBUT)

    Change from baseline in FBUT in seconds (longer is better)

    Time frame: 12 weeks

  51. Change in corneal (central) fluorescein staining score

    Change from baseline in central corneal fluorescein staining score (0-10 worst)

    Time frame: 2 weeks

  52. Change in corneal (central) fluorescein staining score

    Change from baseline in central corneal fluorescein staining score (0-10 worst)

    Time frame: 8 weeks

  53. Change in corneal (central) fluorescein staining score

    Change from baseline in central corneal fluorescein staining score (0-10 worst)

    Time frame: 12 weeks

  54. Change in corneal (inferior) fluorescein staining score

    Change from baseline in inferior corneal fluorescein staining score (0-10 worst)

    Time frame: 2 weeks

  55. Change in corneal (inferior) fluorescein staining score

    Change from baseline in inferior corneal fluorescein staining score (0-10 worst)

    Time frame: 4 weeks

  56. Change in corneal (inferior) fluorescein staining score

    Change from baseline in inferior corneal fluorescein staining score (0-10 worst)

    Time frame: 8 weeks

  57. Change in corneal (inferior) fluorescein staining score

    Change from baseline in inferior corneal fluorescein staining score (0-10 worst)

    Time frame: 12 weeks

  58. Change in corneal (superior) fluorescein staining score

    Change from baseline in superior corneal fluorescein staining score (0-10 worst)

    Time frame: 2 weeks

  59. Change in corneal (superior) fluorescein staining score

    Change from baseline in superior corneal fluorescein staining score (0-10 worst)

    Time frame: 4 weeks

  60. Change in corneal (superior) fluorescein staining score

    Change from baseline in superior corneal fluorescein staining score (0-10 worst)

    Time frame: 8 weeks

  61. Change in corneal (superior) fluorescein staining score

    Change from baseline in superior corneal fluorescein staining score (0-10 worst)

    Time frame: 12 weeks

  62. Change in corneal fluorescein staining sum of scores

    Change from baseline in corneal fluorescein staining sum of scores (0-30 worst)

    Time frame: 2 weeks

  63. Change in corneal fluorescein staining sum of scores

    Change from baseline in corneal fluorescein staining sum of scores (0-30 worst)

    Time frame: 4 weeks

  64. Change in corneal fluorescein staining sum of scores

    Change from baseline in corneal fluorescein staining sum of scores (0-30 worst)

    Time frame: 8 weeks

  65. Change in corneal fluorescein staining sum of scores

    Change from baseline in corneal fluorescein staining sum of scores (0-30 worst)

    Time frame: 12 weeks

  66. Change in conjunctival fluorescein staining sum of scores

    Change from baseline in conjunctival fluorescein staining sum of scores (0-30 worst)

    Time frame: 2 weeks

  67. Change in conjunctival fluorescein staining sum of scores

    Change from baseline in conjunctival fluorescein staining sum of scores (0-30 worst)

    Time frame: 4 weeks

  68. Change in conjunctival fluorescein staining sum of scores

    Change from baseline in conjunctival fluorescein staining sum of scores (0-30 worst)

    Time frame: 8 weeks

  69. Change in conjunctival fluorescein staining sum of scores

    Change from baseline in conjunctival fluorescein staining sum of scores (0-30 worst)

    Time frame: 12 weeks

  70. Change in lissamine green staining (corneal and conjunctival) sum of scores

    Change from baseline in lissamine green staining (corneal and conjunctival) sum of scores

    Time frame: 2 weeks

  71. Change in lissamine green staining (corneal and conjunctival) sum of scores

    Change from baseline in lissamine green staining (corneal and conjunctival) sum of scores (higher is worse)

    Time frame: 4 weeks

  72. Change in lissamine green staining (corneal and conjunctival) sum of scores

    Change from baseline in lissamine green staining (corneal and conjunctival) sum of scores (higher is worse)

    Time frame: 8 weeks

  73. Change in lissamine green staining (corneal and conjunctival) sum of scores

    Change from baseline in lissamine green staining (corneal and conjunctival) sum of scores (higher is worse)

    Time frame: 12 weeks

  74. Change in conjunctival hyperemia (by slit lamp biomicroscopy)

    Change from baseline in conjunctival hyperemia score (0-10 worst)

    Time frame: 2 weeks

  75. Change in conjunctival hyperemia (by slit lamp biomicroscopy)

    Change from baseline in conjunctival hyperemia score (0-10 worst)

    Time frame: 4 weeks

  76. Change in conjunctival hyperemia (by slit lamp biomicroscopy)

    Change from baseline in conjunctival hyperemia score (0-10 worst)

    Time frame: 8 weeks

  77. Change in conjunctival hyperemia (by slit lamp biomicroscopy)

    Change from baseline in conjunctival hyperemia score (0-10 worst)

    Time frame: 12 weeks

07

Study locations

1 site
  • Tri-Service General Hospital, National Defense Medical Center
    Taipei City, 11490, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2021; primary completion for Oct 2021, 5 months later.

How these figures are worked out, and which studies are left out of them.

Registered
May 10, 2021
First posted
May 12, 2021
StartEst.
May 20, 2021
Primary completionEst.
Oct 30, 2021
CompletionEst.
Dec 30, 2021
Last update
May 14, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04884217
Lead sponsor
PharmaDax Inc.
Collaborators
Glia, LLC
Responsible party
Sponsor
First posted
May 12, 2021
Start date
May 20, 2021 (estimated)
Primary completion
Oct 30, 2021 (estimated)
Completion
Dec 30, 2021 (estimated)
Last update
May 14, 2021

Study contacts

Peichun Kuo
study director · PharmaDax Inc.

Oversight

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

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