Special contact lenses aim to soothe dry eyes
NCT ID NCT05973409
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether scleral lenses treated with a special coating called Hydra-PEG can improve comfort and reduce dryness in people with dry eye. 46 participants wore two types of lenses over several weeks and rated their comfort on a scale. The goal was to see if the coated lenses feel better than standard ones.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- scleral lens with Hydra-PEG coating
- What this could lead to
- If successful, this could offer a more comfortable option for managing dry eye symptoms with scleral lenses.
- What could go wrong
- This is a small, completed study with only 46 participants. Results may not apply to everyone with dry eye, and the improvement might be modest.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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46 people
The number who actually took part.
- Started
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Sep 2022
- Finished
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Aug 2023
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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17 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Are at least 17 years of age and have full legal capacity to volunteer; 2. Have read and signed an information consent letter; 3. Are willing and able to follow instructions and maintain the appointment schedule; 4. Agree to wear the study scleral lenses for at least 8 hours per day, 5 days a week; 5. Have a refraction between +20.00 and -20.00D and spectacle astigmatism of no more than -3.00DC in each eye; 6. Have best corrected visual acuity of 20/40 or better in each eye with the study lenses; 7. Demonstrate an acceptable fit with the study lenses; 8. Have no active ocular disease or inflammation; 9. Group 1: Habitual wearer of frequent replacement or daily disposable soft lenses; 10. Group 2: Have not worn contact lenses for 6 months; 11. Group 1: Contact lens wearers should score ≥12 on CLDEQ-8; 12. Group 2: Non contact lens wearers should score ≥13 on OSDI. Exclusion Criteria: 1. Are participating in any concurrent clinical or research study, or have done so within the past 30 days; 2. Cannot achieve a successful lens fit or vision with the study lens; 3. Have been diagnosed with keratoconus or corneal distortion; 4. Have any known active\* ocular condition, disease and/or infection; 5. Have a systemic or ocular condition that in the opinion of the investigator may affect a study outcome variable e.g. pingueculae; 6. Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; 7. Group 2: Non-contact lens wearers who score ≥33 on OSDI and also demonstrate either corneal staining ≥3 (Oxford scale) or non-invasive tear break-up time ≤3 seconds#; 8. Have known sensitivity to the diagnostic sodium fluorescein to be used in the study; 9. Are pregnant, lactating or planning a pregnancy\^ at the time of enrolment, by self report; 10. Have undergone refractive error surgery; 11. Are listed on the Delegation Log for this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
School of Optometry & Vision Sciences
Waterloo, Ontario, N2L 3G1, Canada
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