NCT04541888

Assess the Safety and Efficacy of CsA Ophthalmic Gel in Subjects With Moderate to Severe Dry Eye Disease

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 644 (actual)
• Sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 .

Detailed description

A multicenter,randomized, double-blind, vehicle-controlled Study.Subjects will be randomly assigned to the experimental group and the control group,experimental group: CsA eye gel: 0.3 g: 0.15 mg, once daily;One drop into each eye when you use it.hypromellose eye drops:10ml：50mg,three times a day Control group: vehicle. One drop into the eye, once daily;One drop into each eye when you use it.hypromellose eye drops:10ml：50mg,three times a day

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	CsA Ophthalmic Gel	The CsA eye gel of 0.3 g: 0.15 mg
DRUG	Placebo	Placebo
DRUG	Hypromellose Eye Drop	Hypromellose Eye Drops of 10ml：50mg, 3 times daily, 1-2 drop

Timeline

• Start date: 2020-11-05
• Primary completion: 2021-08-16
• Completion: 2021-10-14
• First posted: 2020-09-09
• Last updated: 2022-04-29

Locations

1 site across 1 country: China