NCT03676335

Assess the Safety and Efficacy of CsA Ophthalmic Gel in Subjects With Dry Eye

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. · Industry
• Sex: All
• Age: 18 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 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.

Detailed description

A multicenter, randomized, single-blind, positive controlled exploratory study will be conducted with cyclosporine A ophthalmic emulsion as the control drug. The experimental drugs were divided into three groups: Treatment group A: CsA eye gel: 0.3 g: 0.15 mg, once daily； Treatment group B: CsA eye gel: 0.3 g: 0.15 mg, twice daily, interval of about 12 hours； Treatment group C: CsA eye gel: 0.3 g: 0.3 mg, once daily. One drop into each eye when you use it. Control group: CsA emulsion: 0.4 ml: 0.2 mg. One drop into the eye, 2 times daily with an interval for 12 hours.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	CsA eye gel	The CsA eye gel of 0.3 g: 0.15 mg, 0.3 g: 0.3 mg
DRUG	CsA for eye emulsion	The CsA for eye emulsion of 0.4 ml: 0.2 mg
DRUG	Hypromellose Eye Drops	Hypromellose Eye Drops of 15ml：75mg, 3 times daily, 1-2 drop

Timeline

• Start date: 2018-05-09
• Primary completion: 2019-06-30
• Completion: 2019-12-12
• First posted: 2018-09-18
• Last updated: 2020-05-08

Locations

1 site across 1 country: China