Comparison of Conjunctival Goblet Cell Density in Dry Eye Patients Treated With Cyclosporine 0.1%… (NCT07368595) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Comparison of Conjunctival Goblet Cell Density in Dry Eye Patients Treated With Cyclosporine 0.1% Dissolved in Perfluorobutylpentane (Vevye®) or Generic 0.05% Cyclosporine Emulsion for 8 Weeks
60 participantsStarted 2026-09-01
Plain-language summary
This goal of this clinical trial is to compare the effects of two approved cyclosporine eye drops that have different concentrations and vehicles on the number of mucus producing conjunctival goblet cells in patients with dry eye disease to learn which one causes the greatest increase.
The main questions it aims to answer are:
Does one drug cause a greater increase in goblet cells? How many weeks does it take to see the difference?
Participants will:
Use the eye drops every day for 2 months Visit the clinic once every 2 weeks for exams and tests
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
. Total cornea fluorescein staining score ≥ 3 based on the modified National Eye Institute (NEI) grading scheme.
. Total conjunctival lissamine green staining score ≥ 2 based on the modified NEI grading scheme. 4. Unanesthetized Schirmer test score ≥ 5 and \< 15mm/5 min in at least 1 eye at the enrollment visit.
Exclusion criteria
. Male or female, 18 years of age or older at enrollment.
. Have a history of DED, clinician diagnosed or patient reported, within the 6 months prior to the enrollment visit.
. Have both of these signs of DED in the same eye at the Enrollment (baseline) visit:
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.
1This trial compares two different cyclosporine eye drop formulations — Vevye at 0.1% versus a generic 0.05% cyclosporine emulsion — so could you explain how the difference in concentration and the type of solution might affect how well each one works for my specific dry eye situation?
2The trial is measuring conjunctival goblet cell density as the primary outcome — can you help me understand what goblet cells are and why tracking their density over 8 weeks would tell us something meaningful about whether my dry eye is actually improving?
3Since this study isn't recruiting yet, how long might it be before I could even potentially participate, and is it worth waiting or should we consider starting one of these treatments now through a standard prescription?
4Both cyclosporine options in this trial are already used for dry eye disease, but the dosing and formulation differ — are there any side effects or tolerability issues with the higher-concentration Vevye formula that I should know about before discussing whether this trial might be worth pursuing?
5As a Phase 4 trial, this is comparing treatments that are already approved, so does that mean the safety profile is better understood than earlier-phase studies, and would standard treatment with one of these cyclosporine options outside the trial be a reasonable alternative for me right now?
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.