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CompletedNCT05079321Updated May 6, 2025Results posted

Ocular Effects of Scleral Lens Wear on Dry Eye Patients

An interventional study of Hydra-PEG and Uncoated in Dry Eye, sponsored by University of Waterloo. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-06.

Sponsored by University of Waterloo · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to investigate the effects of scleral contact lens wear on a DE population using coated (Hydra-PEG) and uncoated (control) lenses. Symptoms of DE, quality of the tear film, quality of life, epithelial and overall corneal thickness, vision and comfort will be assessed before and after dispensing and wearing the lenses for four weeks.

02

Conditions studied

  • Dry Eye
03

In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 192 are open to participants now.

This study's enrollment of 30 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

University of Waterloo is the lead sponsor of 90 studies on the registry; 8 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 9 (75%) have results posted.

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
Yes

Inclusion criteria

A person is eligible for inclusion in the study if he/she:

  • Is at least 18 years of age and has full legal capacity to volunteer.
  • Has read, understood, and signed the information consent letter.
  • Has been diagnosed with dry eyes.
  • Has reduced tear break up time (NITBUT) and/or reduced tear meniscus height (TMH), clinical sign of dry eye disease and contact lens discomfort or is symptomatic of dry eye.
  • Is willing and able to follow instructions and maintain the appointment schedule.
  • Has greater than 13 points on the OSDI.
  • Has greater than 4 points on the Standardized Patient Evaluation of Eye Dryness (SPEED).

Exclusion criteria

Exclusion Criteria:

A person will be excluded from the study if he/she:

  • Is using any topical medications that will likely affect the study outcome.
  • Has undergone any form of corneal surgery.
  • Has any known allergies or sensitivity to the diagnostic pharmaceuticals or products, such as fluorescein, used in this study.
  • Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye not related to the signs of dry eye.
  • Has any clinically significant lid or conjunctival abnormalities and active neovascularization on the cornea.
  • Anatomic variations of the conjunctiva that can impair proper scleral or soft contact lens wear/fitting
  • Ocular pathology other than dry eye (e.g. glaucoma, macular degeneration) which may significantly impact visual function and assessment.
  • Is participating in any other type of eye related clinical or research study.
  • Has any active ocular infection and may require topical medications.
  • Currently taking any systemic medication that may affect the study outcome.
  • Is pregnant
  • Has been diagnosed, recovered, or tested positive but asymptomatic with COVID-19.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Coated Scleral Lens

    Participants wear a lens coated with Hydra-PEG.

    Device: Hydra-PEG

  • Placebo comparator
    Uncoated Scleral Lens

    Participants wear an uncoated (control) lens.

    Device: Uncoated

Interventions

  • DeviceHydra-PEG

    Zen™ RC scleral lenses (Hydra-PEG coated)

  • DeviceUncoated

    Zen™ RC scleral lenses (non-coated)

06

What researchers measure

Primary outcomes

  1. Mean Corneal Thickness

    Mean corneal thickness as measured with Pentacam HR (µm)

    Time frame: At screening

  2. Mean Corneal Thickness

    Mean corneal thickness as measured with Pentacam HR (µm)

    Time frame: After 4 weeks wear of coated lens

  3. Mean Corneal Thickness

    Mean corneal thickness as measured with Pentacam HR (µm)

    Time frame: After 4 weeks wear of uncoated lens

  4. Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score

    The CLDEQ-8 is a validated questionnaire used to quantify symptoms experienced by the contact lenses (CLs) wearer. The participants were asked to respond to 8 questions about how their CLs performed over the preceding 2-week period. 4 questions (Eye discomfort, Eye dryness, Changeable blurry vision and Closing your eyes) answered on a scale of 0=Never to 4=Constantly; 3 questions about the end of wearing time (Discomfort, Dryness, Changeable blurry vision) answered on a scale of 0=Never have it to 5=Very Intense and 1 question (Removing your lenses) on a scale of 1=Never to 6=Several times a day for a total possible score of 1(best) to 37 (worst).

    Time frame: After 2 weeks of wear of coated lens

  5. Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score

    The CLDEQ-8 is a validated questionnaire used to quantify symptoms experienced by the contact lenses (CLs) wearer. The participants were asked to respond to 8 questions about how their CLs performed over the preceding 2-week period. 4 questions (Eye discomfort, Eye dryness, Changeable blurry vision and Closing your eyes) answered on a scale of 0=Never to 4=Constantly; 3 questions about the end of wearing time (Discomfort, Dryness, Changeable blurry vision) answered on a scale of 0=Never have it to 5=Very Intense and 1 question (Removing your lenses) on a scale of 1=Never to 6=Several times a day for a total possible score of 1(best) to 37 (worst).

    Time frame: After 2 weeks of wear of uncoated lens

  6. Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score

    The CLDEQ-8 is a validated questionnaire used to quantify symptoms experienced by the contact lenses (CLs) wearer. The participants were asked to respond to 8 questions about how their CLs performed over the preceding 2-week period. 4 questions (Eye discomfort, Eye dryness, Changeable blurry vision and Closing your eyes) answered on a scale of 0=Never to 4=Constantly; 3 questions about the end of wearing time (Discomfort, Dryness, Changeable blurry vision) answered on a scale of 0=Never have it to 5=Very Intense and 1 question (Removing your lenses) on a scale of 1=Never to 6=Several times a day for a total possible score of 1(best) to 37 (worst).

    Time frame: After 4 weeks of wear of coated lens

  7. Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score

    The CLDEQ-8 is a validated questionnaire used to quantify symptoms experienced by the contact lenses (CLs) wearer. The participants were asked to respond to 8 questions about how their CLs performed over the preceding 2-week period. 4 questions (Eye discomfort, Eye dryness, Changeable blurry vision and Closing your eyes) answered on a scale of 0=Never to 4=Constantly; 3 questions about the end of wearing time (Discomfort, Dryness, Changeable blurry vision) answered on a scale of 0=Never have it to 5=Very Intense and 1 question (Removing your lenses) on a scale of 1=Never to 6=Several times a day for a total possible score of 1(best) to 37 (worst).

    Time frame: After 4 weeks of wear of uncoated lens

  8. Tear Film Osmolarity

    Tear film osmolarity measures with a Tearlab Osmolarity System

    Time frame: At screening

  9. Tear Film Osmolarity

    Tear film osmolarity measures with a Tearlab Osmolarity System

    Time frame: After 4 weeks of wear of uncoated lens

  10. Tear Film Osmolarity

    Tear film osmolarity measures with a Tearlab Osmolarity System

    Time frame: After 4 weeks of wear of coated lens

  11. Contact Lens Impact on Quality of Life (CLIQ) Questionnaire Score

    This self-administered Contact Lens Impact on Quality of Life (CLIQ) questionnaire uses 28-item questions which are categorized into five main parameters: daily activities, eye symptoms, functional vision, psychometric properties, and refractive correction. Each question has a five-step response scale (none = 1; little = 2; moderate = 3; extreme = 4 and unable = 5). The responses are computed using the formula: CLIQperson measure = 34.41 × log (CLIQraw score/5 - CLIQraw score) + 26.69. This is then analyzed on a scale from 0 to 100, where higher scores indicate better QoL.

    Time frame: After 4 weeks of wear of uncoated lens

  12. Contact Lens Impact on Quality of Life (CLIQ) Questionnaire Score

    This self-administered Contact Lens Impact on Quality of Life (CLIQ) questionnaire uses 28-item questions which are categorized into five main parameters: daily activities, eye symptoms, functional vision, psychometric properties, and refractive correction. Each question has a five-step response scale (none = 1; little = 2; moderate = 3; extreme = 4 and unable = 5). The responses are computed using the formula: CLIQperson measure = 34.41 × log (CLIQraw score/5 - CLIQraw score) + 26.69. This is then analyzed on a scale from 0 to 100, where higher scores indicate better QoL.

    Time frame: After 4 weeks of wear of coated lens

  13. Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film

    Percentage of participants with a positive MMP-9 test, as measured by InflammaDry

    Time frame: At screening

  14. Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film

    Percentage of participants with a positive MMP-9 test, as measured by InflammaDry

    Time frame: After 4 weeks of wear of coated lens

  15. Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film

    Percentage of participants with a positive MMP-9 test, as measured by InflammaDry

    Time frame: After 4 weeks of wear of uncoated lens

07

Results

Posted May 6, 2025

Participant flow

Participants were recruited at a single site between April 2022 and October 2022. The first participant was enrolled on April 14, 2022 and the last participant was enrolled on October 25, 2022.

Participant flow — Overall Study
MilestoneCoated/Uncoated Scleral LensUncoated/Coated Scleral Lens
Started1213
Completed1010
Not completed23
Withdrew: Withdrawal by subject22
Withdrew: Lost to follow-up01

Outcome measures

PrimaryMean Corneal Thickness

Mean corneal thickness as measured with Pentacam HR (µm)

Time frame:
At screening
Reported as:
Mean · microns
Mean Corneal Thickness
micronsCoated/Uncoated Scleral LensUncoated/Coated Scleral Lens
Mean Corneal Thickness570.54 ± 38.97560.73 ± 31.48
Statistical analysis
  • Coated/Uncoated Scleral Lens vs Uncoated/Coated Scleral Lens · t-test, 2 sided · p = 0.25
PrimaryMean Corneal Thickness

Mean corneal thickness as measured with Pentacam HR (µm)

Time frame:
After 4 weeks wear of coated lens
Reported as:
Mean · microns
Mean Corneal Thickness
micronsCoated/Uncoated Scleral LensUncoated/Coated Scleral Lens
Mean Corneal Thickness552.70 ± 26.96559.85 ± 35.31
Statistical analysis
  • Coated/Uncoated Scleral Lens vs Uncoated/Coated Scleral Lens · t-test, 2 sided · p = 0.36
PrimaryMean Corneal Thickness

Mean corneal thickness as measured with Pentacam HR (µm)

Time frame:
After 4 weeks wear of uncoated lens
Reported as:
Mean · microns
Mean Corneal Thickness
micronsCoated Scleral LensUncoated Scleral Lens
Mean Corneal Thickness556.91 ± 29.83556.87 ± 29.92
Statistical analysis
  • Coated Scleral Lens vs Uncoated Scleral Lens · t-test, 2 sided · p = 1.0
PrimaryContact Lens Dry Eye Questionnaire (CLDEQ-8) Score

The CLDEQ-8 is a validated questionnaire used to quantify symptoms experienced by the contact lenses (CLs) wearer. The participants were asked to respond to 8 questions about how their CLs performed over the preceding 2-week period. 4 questions (Eye discomfort, Eye dryness, Changeable blurry vision and Closing your eyes) answered on a scale of 0=Never to 4=Constantly; 3 questions about the end of wearing time (Discomfort, Dryness, Changeable blurry vision) answered on a scale of 0=Never have it to 5=Very Intense and 1 question (Removing your lenses) on a scale of 1=Never to 6=Several times a day for a total possible score of 1(best) to 37 (worst).

Time frame:
After 2 weeks of wear of coated lens
Reported as:
Mean · score on a scale
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score
score on a scaleCoated/Uncoated Scleral LensUncoated/Coated Scleral Lens
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score14.10 ± 7.9220.30 ± 5.56
Statistical analysis
  • Coated/Uncoated Scleral Lens vs Uncoated/Coated Scleral Lens · t-test, 2 sided · p = 0.06
PrimaryContact Lens Dry Eye Questionnaire (CLDEQ-8) Score

The CLDEQ-8 is a validated questionnaire used to quantify symptoms experienced by the contact lenses (CLs) wearer. The participants were asked to respond to 8 questions about how their CLs performed over the preceding 2-week period. 4 questions (Eye discomfort, Eye dryness, Changeable blurry vision and Closing your eyes) answered on a scale of 0=Never to 4=Constantly; 3 questions about the end of wearing time (Discomfort, Dryness, Changeable blurry vision) answered on a scale of 0=Never have it to 5=Very Intense and 1 question (Removing your lenses) on a scale of 1=Never to 6=Several times a day for a total possible score of 1(best) to 37 (worst).

Time frame:
After 2 weeks of wear of uncoated lens
Reported as:
Mean · score on a scale
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score
score on a scaleCoated/Uncoated Scleral LensUncoated/Coated Scleral Lens
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score19.40 ± 7.3417.20 ± 6.55
Statistical analysis
  • Coated/Uncoated Scleral Lens vs Uncoated/Coated Scleral Lens · t-test, 2 sided · p = 0.49
PrimaryContact Lens Dry Eye Questionnaire (CLDEQ-8) Score

The CLDEQ-8 is a validated questionnaire used to quantify symptoms experienced by the contact lenses (CLs) wearer. The participants were asked to respond to 8 questions about how their CLs performed over the preceding 2-week period. 4 questions (Eye discomfort, Eye dryness, Changeable blurry vision and Closing your eyes) answered on a scale of 0=Never to 4=Constantly; 3 questions about the end of wearing time (Discomfort, Dryness, Changeable blurry vision) answered on a scale of 0=Never have it to 5=Very Intense and 1 question (Removing your lenses) on a scale of 1=Never to 6=Several times a day for a total possible score of 1(best) to 37 (worst).

Time frame:
After 4 weeks of wear of coated lens
Reported as:
Mean · score on a scale
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score
score on a scaleCoated/Uncoated Scleral LensUncoated/Coated Scleral Lens
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score13.50 ± 7.0719.50 ± 6.64
Statistical analysis
  • Coated/Uncoated Scleral Lens vs Uncoated/Coated Scleral Lens · t-test, 2 sided · p = 0.07
PrimaryContact Lens Dry Eye Questionnaire (CLDEQ-8) Score

The CLDEQ-8 is a validated questionnaire used to quantify symptoms experienced by the contact lenses (CLs) wearer. The participants were asked to respond to 8 questions about how their CLs performed over the preceding 2-week period. 4 questions (Eye discomfort, Eye dryness, Changeable blurry vision and Closing your eyes) answered on a scale of 0=Never to 4=Constantly; 3 questions about the end of wearing time (Discomfort, Dryness, Changeable blurry vision) answered on a scale of 0=Never have it to 5=Very Intense and 1 question (Removing your lenses) on a scale of 1=Never to 6=Several times a day for a total possible score of 1(best) to 37 (worst).

Time frame:
After 4 weeks of wear of uncoated lens
Reported as:
Mean · score on a scale
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score
score on a scaleCoated/Uncoated Scleral LensUncoated/Coated Scleral Lens
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score18.60 ± 7.9915.10 ± 7.65
Statistical analysis
  • Coated/Uncoated Scleral Lens vs Uncoated/Coated Scleral Lens · t-test, 2 sided · p = 0.33
PrimaryTear Film Osmolarity

Tear film osmolarity measures with a Tearlab Osmolarity System

Time frame:
At screening
Reported as:
Mean · mOsm/l
Tear Film Osmolarity
mOsm/lCoated/Uncoated Scleral LensUncoated/Coated Scleral Lens
Tear Film Osmolarity313.29 ± 22.18309.69 ± 16.32
Statistical analysis
  • Coated/Uncoated Scleral Lens vs Uncoated/Coated Scleral Lens · t-test, 2 sided · p = 0.65
PrimaryTear Film Osmolarity

Tear film osmolarity measures with a Tearlab Osmolarity System

Time frame:
After 4 weeks of wear of uncoated lens
Reported as:
Mean · mOsm/l
Tear Film Osmolarity
mOsm/lCoated Scleral LensUncoated Scleral Lens
Tear Film Osmolarity300.00 ± 12.87306.05 ± 12.87
PrimaryTear Film Osmolarity

Tear film osmolarity measures with a Tearlab Osmolarity System

Time frame:
After 4 weeks of wear of coated lens
Reported as:
Mean · mOsm/l
Tear Film Osmolarity
mOsm/lCoated/Uncoated Scleral LensUncoated/Coated Scleral Lens
Tear Film Osmolarity304.40 ± 8.48303.90 ± 11.57
Statistical analysis
  • Coated/Uncoated Scleral Lens vs Uncoated/Coated Scleral Lens · t-test, 2 sided · p = 0.91
PrimaryContact Lens Impact on Quality of Life (CLIQ) Questionnaire Score

This self-administered Contact Lens Impact on Quality of Life (CLIQ) questionnaire uses 28-item questions which are categorized into five main parameters: daily activities, eye symptoms, functional vision, psychometric properties, and refractive correction. Each question has a five-step response scale (none = 1; little = 2; moderate = 3; extreme = 4 and unable = 5). The responses are computed using the formula: CLIQperson measure = 34.41 × log (CLIQraw score/5 - CLIQraw score) + 26.69. This is then analyzed on a scale from 0 to 100, where higher scores indicate better QoL.

Time frame:
After 4 weeks of wear of uncoated lens
Reported as:
Mean · score on a scale
Contact Lens Impact on Quality of Life (CLIQ) Questionnaire Score
score on a scaleCoated/Uncoated Scleral LensUncoated/Coated Scleral Lens
Contact Lens Impact on Quality of Life (CLIQ) Questionnaire Score37.66 ± 13.3739.67 ± 9.78
Statistical analysis
  • Coated/Uncoated Scleral Lens vs Uncoated/Coated Scleral Lens · t-test, 2 sided · p = 0.71
PrimaryContact Lens Impact on Quality of Life (CLIQ) Questionnaire Score

This self-administered Contact Lens Impact on Quality of Life (CLIQ) questionnaire uses 28-item questions which are categorized into five main parameters: daily activities, eye symptoms, functional vision, psychometric properties, and refractive correction. Each question has a five-step response scale (none = 1; little = 2; moderate = 3; extreme = 4 and unable = 5). The responses are computed using the formula: CLIQperson measure = 34.41 × log (CLIQraw score/5 - CLIQraw score) + 26.69. This is then analyzed on a scale from 0 to 100, where higher scores indicate better QoL.

Time frame:
After 4 weeks of wear of coated lens
Reported as:
Mean · score on a scale
Contact Lens Impact on Quality of Life (CLIQ) Questionnaire Score
score on a scaleCoated/Uncoated Scleral LensUncoated/Coated Scleral Lens
Contact Lens Impact on Quality of Life (CLIQ) Questionnaire Score40.70 ± 9.4940.54 ± 11.31
Statistical analysis
  • Coated/Uncoated Scleral Lens vs Uncoated/Coated Scleral Lens · t-test, 2 sided · p = 0.97
PrimaryPercentage of Participants With MMP-9 Inflammatory Marker in Tear Film

Percentage of participants with a positive MMP-9 test, as measured by InflammaDry

Time frame:
At screening
Reported as:
Number · percentage of participants
Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film
percentage of participantsCoated/Uncoated Scleral LensUncoated/Coated Scleral Lens
Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film83.3384.62
Statistical analysis
  • Coated/Uncoated Scleral Lens vs Uncoated/Coated Scleral Lens · Fisher Exact · p = 0.75
PrimaryPercentage of Participants With MMP-9 Inflammatory Marker in Tear Film

Percentage of participants with a positive MMP-9 test, as measured by InflammaDry

Time frame:
After 4 weeks of wear of coated lens
Reported as:
Number · percentage of participants
Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film
percentage of participantsCoated/Uncoated Scleral LensUncoated/Coated Scleral Lens
Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film8070
Statistical analysis
  • Coated/Uncoated Scleral Lens vs Uncoated/Coated Scleral Lens · Fisher Exact · p = 0.59
PrimaryPercentage of Participants With MMP-9 Inflammatory Marker in Tear Film

Percentage of participants with a positive MMP-9 test, as measured by InflammaDry

Time frame:
After 4 weeks of wear of uncoated lens
Reported as:
Number · percentage of participants
Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film
percentage of participantsCoated/Uncoated Scleral LensUncoated/Coated Scleral Lens
Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film5060
Statistical analysis
  • Coated/Uncoated Scleral Lens vs Uncoated/Coated Scleral Lens · Fisher Exact · p = 0.69

Adverse events

Collected over Maximum of three months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Coated Scleral Lens0/22 (0%)0/22 (0%)0/22 (0%)
Uncoated Scleral Lens0/23 (0%)0/23 (0%)0/23 (0%)

Baseline characteristics

All suitable participants eligible to participate in the study.

Age, Categorical
Age, Categorical(Participants)Overall Group
<=18 years0
Between 18 and 65 years28
>=65 years0
Age, Continuous
Age, Continuous(years)Overall Group
Mean28.79 ± 7.61
Sex: Female, Male
Sex: Female, Male(Participants)Overall Group
Female24
Male4
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Overall Group
Race — Asian12
Race — Caucasian8
Race — African/Black2
Race — Indian4
Race — Arab2
Region of Enrollment
Region of Enrollment(participants)Overall Group
Canada28
08

Study locations

1 site
  • School of Optometry & Vision Science, University of Waterloo
    Waterloo, Ontario N2L 3G1, Canada
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Sep 17, 2021

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

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
NCT05079321
Lead sponsor
University of Waterloo
Responsible party
Sponsor
First posted
Oct 15, 2021
Start date
Apr 14, 2022
Primary completion
Aug 28, 2023
Completion
Aug 28, 2023
Results posted
May 6, 2025
Last update
May 6, 2025

Study contacts

Lyndon Jones, PhD, FCOptom
principal investigator · University of Waterloo

Oversight

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

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