At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 644 enrolled
Drug / intervention
CsA Ophthalmic Gel +2 moredrug
Likely dose
CsA Ophthalmic Gel 0.3 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Multicenter, Randomized, Double-blind, Vehicle-controlled Efficacy and Safety Study of CsA Ophthalmic Gel in Subjects With Moderate to Severe Dry Eye Disease
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.·interventional·Posted Sep 9, 2020·Updated Apr 29, 2022
In Brief
A Phase 3 clinical trial evaluating CsA Ophthalmic Gel, Placebo, and 1 other intervention for Dry Eye. Completed, enrolled 644 participants across 1 site.
Detailed Summary
The purpose of this study is to explore the efficacy and safety of CsA ophthalmic gel in the treatment of moderate to severe dry eye disease .
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye
CountriesChina
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedSep 2020
Enrollment StartNov 2020
Primary CompletionAug 2021
Study CompletionOct 2021
TodayJul 2026
First PostedSep 9, 2020
Enrollment StartNov 5, 2020
Primary CompletionAug 16, 2021
Study CompletionOct 14, 2021
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.8 years ago
Interventions
CsA Ophthalmic Geldrug
The CsA eye gel of 0.3 g: 0.15 mg
Placebodrug
Placebo
Hypromellose Eye Dropdrug
Hypromellose Eye Drops of 10ml：50mg, 3 times daily, 1-2 drop