Observational Study on the Efficacy and Tolerance of EYEBRID Lenses (NCT05036954) | Clinical Trial Compass
UnknownNot Applicable
Observational Study on the Efficacy and Tolerance of EYEBRID Lenses
France60 participantsStarted 2021-09-30
Plain-language summary
Technical advances in lenses are continuous and materials are improved. We provide a prospective longitudinal observational study evaluating the efficacy and safety of new EyeBrid Excel hybrid lenses (LCS) in the treatment of severe ametropia and for patients with corneal irregularities.
This study should include 60 patients for a period of three months. The aim of this work is to assess the improvement in the best corrected visual acuity and the good tolerance of this lens.
Who can participate
Age range
18 Years – 80 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:
* o Wear rigid lenses and complain about their lenses (discomfort, loss, poor vision) or
* Wear rigid lenses and have objective intolerances (damage to surfaces related to rigid lenses) or
* Are new wearers of lenses and presenting a strong ametropia (Strong myopia from -5.00 to -30.00d, strong hyperopia from + 4.50d to + 30.00d, strong astigmatism from 2.50d to 12.00d), with or without presbyopia (Addition of 0.75d to 3.50d)
* Any patient diagnosed with Keratoconus stages 1 to 3.
* Be affiliated to the social security system
Exclusion Criteria:
* Patient with contraindications to wearing contact lenses
* Pregnant or breastfeeding woman
* Any minor or over 80 years old
* Any infection, inflammation or abnormality of the anterior segments
* Progressive ocular disorder of the anterior segments for which the wearing of contact lenses would be discouraged;
* Use of systemic or ocular treatment products for which the wearing of contact lenses would be discouraged;
* History of any herpetic keratitis;
* History of any refractive surgery or any irregular cornea (except in cases where the contact lenses examined may be worn by a subject with an irregular cornea, suffering from keratoconus or having undergone refractive surgery);
* Slit lamp observations of greater than grade 1 gravity;
* Vascularization of the cornea with a penetration greater than 1 mm;
* Case of pathological dry eye;
* When a subject has participated in a clinical trial on contact lenses…
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.