Investigation in Corneal Sensation and Contact Lens Wear (NCT04804592) | Clinical Trial Compass
CompletedNot Applicable
Investigation in Corneal Sensation and Contact Lens Wear
Switzerland111 participantsStarted 2021-05-01
Plain-language summary
The aim is to find out more about how corneal sensory fibres react to different types of stimuli (liquid / tactile / nylon thread) and how this can be consciously perceived by the individual. Is it possible to generate a stimulus that delivers a repeatable and reliable response within a useful stimulus force range which allows an interpretation / evaluation of normal / expected activity of superficial nerve fibres in the cornea? The study group will be divided into three groups of individuals: two groups with different types of contact lenses (CL) and one without CL, as sensitivity changes are thought to occur with CL wear. A very interesting research question is to find out, if such sensitivity differences can be detected with the nature of the stimuli applied in this study.
Who can participate
Age range
18 Years – 50 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:
Group A:
Silicone hydrogel (SiHy) CL wear at least 3 days per week and at least 8 hours per day; 18 - 50 years of age; healthy eyes with OSDI \</= 13
Group B:
Rigid gas permeable (RGP) CL wear at least 3 days per week and at least 8 hours per day; 18 - 50 years of age; healthy eyes with OSDI \</= 13
Group C:
No current CL wear for at least 3 months; 18 - 50 years of age; healthy eyes with OSDI \</= 13
Exclusion Criteria:
* Systemic disease that may affect ocular health, such as diabetes
* Injury and history of operations on the anterior segment of the eye
* regular application of systemic or ocular medication known to affect the tear film, specifically on the day of measurement
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
Repeatability of mechanical corneal sensation thresholds with the liquid jet protoype esthesiometer
Timeframe: two weeks
2
Repeatability of mechanical corneal sensation thresholds with the tactile prototype esthesiometer
Timeframe: two weeks
3
Repeatability of mechanical corneal sensation thresholds with the Cochet Bonnet esthesiometer