Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjec… (NCT04147650) | Clinical Trial Compass
CompletedPhase 2/3
Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrome
United States508 participantsStarted 2019-10-14
Plain-language summary
A Multi-Center, Phase 2/3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Voclosporin Ophthalmic Solution (0.05%, 0.10%, 0.20%) Compared to Vehicle in Subjects with Dry Eye Syndrome.
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.
* Have a documented history of Dry Eye prior to Visit 1.
* Willing and able to follow protocol procedures and instructions.
Exclusion criteria:
* Have undergone cataract or LASIK surgery within 1 year prior to Visit 1.
* Recent or current evidence of infection or inflammation in either eye.
* Current evidence of blepharitis, other meibomian gland dysfunction, conjunctivitis or history of herpes simplex or zoster keratitis in either eye.
* Have used any investigational drug or device within 30 days prior to Visit 1.
* Have used ophthalmic drugs (any topical eye medications) including prescription medication and over the counter (OTC) agents on the date of Visit 1.
* Have worn contact lenses 24 hours prior to Visit 1.
* Have used Xiidra® (lifitegrast) within 14 days prior to Visit 1.
* Have used Calcineurin Inhibitors (CNIs) such as Restasis® (cyclosporin ophthalmic emulsion) or CequaTM within 30 days prior to Visit 1.
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 tested different doses of voclosporin eye drops for dry eye — since it's now completed, has the data been published, and what do the results show about whether any dose actually improved tear production compared to a placebo?
2The trial measured success as a 10 mm or greater improvement on the Schirmer Tear Test, which measures how much the eye produces tears — is my current level of tear production severe enough that this kind of improvement would be meaningful for my specific situation?
3Since this was a Phase 2/3 study, what does that mean for how much we know about the long-term safety of voclosporin eye drops, and are there any side effects that showed up in the trial that I should be aware of?
4Given that this trial is now completed, is voclosporin eye drops moving toward FDA approval, or are there other ongoing studies I might be eligible for if my dry eye disease isn't well controlled on current treatments?
5Before considering a newer treatment like this one, should I try or exhaust standard dry eye therapies first — like cyclosporine drops already on the market — and how would my doctor decide when it makes sense to look at something newer?
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
Number of Subjects With a ≥10 mm Increase From Baseline in Schirmer Tear Test (STT)