A Clinical Trial to Evaluate the Corneal Endothelial Health of DED Subjects Treated With Cyclospo… (NCT06329661) | Clinical Trial Compass
CompletedPhase 4
A Clinical Trial to Evaluate the Corneal Endothelial Health of DED Subjects Treated With Cyclosporine
United States204 participantsStarted 2024-04-22
Plain-language summary
The objective of this trial is to evaluate the effect of cyclosporine ophthalmic solution, 0.1% on corneal endothelial cell health in comparison to a hypotonic saline solution in subjects with Dry Eye Disease (DED)
Who can participate
Age range
18 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:
* Be at least 18 years of age;
* Provide written informed consent;
* Have a subject reported history of dry eye disease (DED) in both eyes
* Be able and willing to follow instructions, including participation in all trial assessments and visits.
Exclusion Criteria:
* Be a woman who is pregnant, nursing, or planning a pregnancy;
* Unwillingness to submit a urine pregnancy test at screening and the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control
* Clinically significant slit-lamp findings or abnormal lid anatomy at screening
* Ocular/periocular malignancy
* History of herpetic keratitis
* Have any primary or secondary corneal endothelial disorder such as Fuchs dystrophy or other endothelial dystrophy, significant guttata
* Ongoing ocular or systemic infection at screening or baseline
* Presence of uncontrolled systemic diseases
* Presence of known allergy and/or sensitivity to the study drug or its components
* Intraocular surgery or ocular laser surgery or significant trauma within 365 days before Visit 1, or have any planned ocular surgeries during the trial period;
* Have a known allergy or sensitivity to the IMP or its components
* Have a condition or be in a situation which the Investigator feels may put the subject at significant risk, may confound the trial results, or may interfere with the subject's participation in the trial significantly.
* Randomized in a previous …
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.