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Special contact lenses aim to soothe dry eyes

NCT ID NCT05973409

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

46 people

The number who actually took part.

Started

Sep 2022

Finished

Aug 2023

Lead sponsor

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

17 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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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