Dry EyeNCT05079321
Ocular Effects of Scleral Lens Wear on Dry Eye Patients
A study testing Hydra-PEG and Uncoated in people with Dry Eye, run by University of Waterloo at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Hydra-PEG and Uncoated
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 14 Apr 2022to 28 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
School of Optometry & Vision Science, University of Waterloo
Waterloo, Ontario, N2L 3G1
About this study
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.
- Conditions
- Dry Eye
- Being tested
- Hydra-PEG, Uncoated
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydra-PEGDevice
Zen™ RC scleral lenses (Hydra-PEG coated)
UncoatedDevice
Zen™ RC scleral lenses (non-coated)
| Study group | Role | What they receive |
|---|---|---|
| Coated Scleral Lens | Experimental | Participants wear a lens coated with Hydra-PEG. Receives: Device: Hydra-PEG |
| Uncoated Scleral Lens | Placebo comparator | Participants wear an uncoated (control) lens. Receives: Device: Uncoated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Corneal Thickness
Mean corneal thickness as measured with Pentacam HR (µm)
Measured: At screening
Mean Corneal Thickness
Mean corneal thickness as measured with Pentacam HR (µm)
Measured: After 4 weeks wear of coated lens
Mean Corneal Thickness
Mean corneal thickness as measured with Pentacam HR (µm)
Measured: After 4 weeks wear of uncoated lens
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).
Measured: After 2 weeks of wear of coated lens
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).
Measured: After 2 weeks of wear of uncoated lens
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).
Measured: After 4 weeks of wear of coated lens
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).
Measured: After 4 weeks of wear of uncoated lens
Tear Film Osmolarity
Tear film osmolarity measures with a Tearlab Osmolarity System
Measured: At screening
Tear Film Osmolarity
Tear film osmolarity measures with a Tearlab Osmolarity System
Measured: After 4 weeks of wear of uncoated lens
Tear Film Osmolarity
Tear film osmolarity measures with a Tearlab Osmolarity System
Measured: After 4 weeks of wear of coated lens
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.
Measured: After 4 weeks of wear of uncoated lens
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.
Measured: After 4 weeks of wear of coated lens
Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film
Percentage of participants with a positive MMP-9 test, as measured by InflammaDry
Measured: At screening
Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film
Percentage of participants with a positive MMP-9 test, as measured by InflammaDry
Measured: After 4 weeks of wear of coated lens
Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film
Percentage of participants with a positive MMP-9 test, as measured by InflammaDry
Measured: After 4 weeks of wear of uncoated lens
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start14 Apr 2022
- Primary completion28 Aug 2023
- Study completion28 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lyndon Jones, PhD, FCOptom, Principal investigator, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079321
- Sponsor's protocol ID
- 40887
- Status last verified
- Nov 2023
- First submitted
- 1 Oct 2021
- Last updated
- 6 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Effects of Scleral Lens Wear on Dry Eye Patients
- ClinicalTrials.gov ID
- NCT05079321
- Acronym / sponsor ID
- 40887
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 28 Aug 2023 (actual)
- Study completion
- 28 Aug 2023 (actual)
- First posted
- 15 Oct 2021 (actual)
- Results
- Posted 6 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coated Scleral Lens | Experimental | Device: Hydra-PEGParticipants wear a lens coated with Hydra-PEG. |
| Uncoated Scleral Lens | Placebo comparator | Device: UncoatedParticipants wear an uncoated (control) lens. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydra-PEGZen™ RC scleral lenses (Hydra-PEG coated) | Device | Coated Scleral Lens |
| UncoatedZen™ RC scleral lenses (non-coated) | Device | Uncoated Scleral Lens |
Primary outcome
Mean Corneal Thickness
Time frame: At screening
Mean corneal thickness as measured with Pentacam HR (µm)
Mean Corneal Thickness
Time frame: After 4 weeks wear of coated lens
Mean corneal thickness as measured with Pentacam HR (µm)
Mean Corneal Thickness
Time frame: After 4 weeks wear of uncoated lens
Mean corneal thickness as measured with Pentacam HR (µm)
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score
Time frame: After 2 weeks of wear of coated lens
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).
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score
Time frame: After 2 weeks of wear of uncoated lens
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).
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score
Time frame: After 4 weeks of wear of coated lens
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).
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score
Time frame: After 4 weeks of wear of uncoated lens
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).
Tear Film Osmolarity
Time frame: At screening
Tear film osmolarity measures with a Tearlab Osmolarity System
Tear Film Osmolarity
Time frame: After 4 weeks of wear of uncoated lens
Tear film osmolarity measures with a Tearlab Osmolarity System
Tear Film Osmolarity
Time frame: After 4 weeks of wear of coated lens
Tear film osmolarity measures with a Tearlab Osmolarity System
Contact Lens Impact on Quality of Life (CLIQ) Questionnaire Score
Time frame: After 4 weeks of wear of uncoated lens
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.
Contact Lens Impact on Quality of Life (CLIQ) Questionnaire Score
Time frame: After 4 weeks of wear of coated lens
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.
Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film
Time frame: At screening
Percentage of participants with a positive MMP-9 test, as measured by InflammaDry
Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film
Time frame: After 4 weeks of wear of coated lens
Percentage of participants with a positive MMP-9 test, as measured by InflammaDry
Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film
Time frame: After 4 weeks of wear of uncoated lens
Percentage of participants with a positive MMP-9 test, as measured by InflammaDry
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lyndon Jones, PhD, FCOptom principal investigator
University of Waterloo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydra-PEG and Uncoated in people with Dry Eye, run by University of Waterloo at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Corneal Thickness (time frame: At screening). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.