Influence of Silicone Hydrogel Contact Lens Neophyte Wear on Corneal Sensitivity (NCT05745220) | Clinical Trial Compass
CompletedNot Applicable
Influence of Silicone Hydrogel Contact Lens Neophyte Wear on Corneal Sensitivity
Switzerland42 participantsStarted 2023-04-08
Plain-language summary
Soft contact lenses can affect the ocular surface and sometimes cause intolerance. The aim of this study is to measure corneal sensitivity using the Swiss Liquid Jet aesthesiometer at baseline, after one and after six weeks, in novice daily contact lens wearers.
Who can participate
Age range
18 Years – 38 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The Ocular Surface Disease Index questionnaire (OSDI) score for dry eye classification is ≤ 13
* Participants must be candidates for contact lens wear.
* Corneal radius between 7.4mm and 8.0mm
* If the corneal radius is \> 8.0mm, the corneal diameter must be greater than 12.0mm.
* If the corneal radius is \<7.4mm, the required corneal diameter is less than 12.0mm.
* Participants have a CL cylindrical ametropia ≤ -1.25 D.
* Participants will not have worn CL for 7 days prior to the start of the study.
* Participants do not wear CL regularly (no more than 1 days per week) prior to the start of the study.
* During the study, the participant wore the CL a minimum of 5 days per week for a minimum of 8 hours.
* The person being tested is in good health. This means that he or she does not suffer from any systemic diseases, such as diabetes or rheumatism, which could have an influence on eye health. He or she also has no eye disease and has not previously undergone corneal (refractive) surgery.
Exclusion Criteria:
* The participant is a minor.
* The participant has worn CL within the last 7 days.
* The radius of the cornea is not within the prescribed range. In addition, the corneal diameter is not within the prescribed range either.
* The participant's ametropia is not within the prescribed range.
* The participant has worn the lenses for less than 8 hours for less than five days.
* The participant has no diagnosis of dry eye.
* The OSDI questionnaire score …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in corneal sensitivity threshold baseline and after one and six weeks of daily contact lens wear