Not Yet RecruitingPhase 3

Phase III Study of OT202 in Treating Moderate to Severe Dry Eye

China842 participantsStarted 2026-08

Plain-language summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial, enrolling 842 subjects with moderate to severe dry eye, who will be randomized at a 1:1 ratio to receive either 1% OT202 ophthalmic solution or vehicle control. The trial consists of screening, run-in, 8-week double-blind treatment period, and three long-term safety follow-up cohorts (10 weeks, 28 weeks, and 54 weeks), including 342 subjects for the 10-week follow-up, 350 subjects for the 28-week follow-up, and 150 subjects for the 54-week follow-up. Unblinding will be performed after the completion of double-blind treatment for all subjects, who will then receive open-label 1% OT202 ophthalmic solution uniformly. The co-primary efficacy endpoints are the change from baseline in Total Corneal Fluorescein Staining Score (TCSS) and Visual Analog Scale-Eye Dryness Score (VAS-EDS) at Day 56. Pharmacokinetic assessments will be conducted in 60 of the subjects assigned to the 54-weeks long-term safety follow-up. An interim futility analysis will be performed once approximately 30% of subjects complete the treatment period. Analysis of covariance (ANCOVA) will be utilized for efficacy statistical analyses. The primary objective is to evaluate the efficacy and safety of OT202 ophthalmic solution in the treatment of moderate to severe dry eye.

Who can participate

Age range

30 Years – 75 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

. 30 to 75 years of age (inclusive) at the time of signing the ICF, either sex or ethnic group.
. With history of dry eye for at least 6 months prior to screening, and history of use or willingness to use eye drops for the treatment of dry eye within 6 months prior to screening.
. Binocular BCVA ≥ 0.25 decimals (standard logarithmic visual acuity chart) at Screening and Baseline.
. At least one eye (the same eye) meets all the following criteria at screening and baseline:
. Must be able to understand and sign the ICF approved by Independent Ethics Committee (EC).
. Willing and able to conduct protocol-required study visits, follow study guidelines, and take study drug as instructed.

Exclusion criteria

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.

What they're measuring

Total Corneal Fluorescein Staining (TCSS) score

Timeframe: Day 56

Total visual analogue scale (VAS)-eye dryness score (EDS) score

Timeframe: Day 56

Trial details

NCT IDNCT07740564

SponsorOcumension Therapeutics (Suzhou) Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-01

Contact for this trial

Wei Chen

0577-88075582 chenwei@eye.ac.cn

View on ClinicalTrials.gov More Dry Eye trials