At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase Ⅱ, Multicenter, Randomized, Single-blind, Positive-controlled, Dose-finding Study to Assess the Efficacy and Safety of CsA Ophthalmic Gel in Subjects With Moderate to Severe Aqueous-Deficient Dry Eye (ADDE)
In Brief
A Phase 2 clinical trial evaluating CsA eye gel, CsA for eye emulsion, and 1 other intervention for Dry Eye. Completed, enrolled 240 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 tear deficiency dry eye with different dosage, frequency and concentration, and to preliminarily determine the optimal dosage, frequency and concentration, so as to provide a theoretical basis for the design of follow-up clinical studies.
Study Details
Timeline
Interventions
The CsA eye gel of 0.3 g: 0.15 mg, 0.3 g: 0.3 mg
The CsA for eye emulsion of 0.4 ml: 0.2 mg
Hypromellose Eye Drops of 15ml：75mg, 3 times daily, 1-2 drop