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 range18 Years
SexALL
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 …