NCT06942793

A Study to Evaluate the Efficacy and Safety of Treatment With CsA-PG Ophthalmic Gel in Dry Eye Patients

A Phase 3, Multicenter, Randomized, Double-Masked, Active-Controlled Study to Evaluate the Efficacy and Safety of Treatment With CsA-PG Ophthalmic Gel in Dry Eye Patients

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 396 (estimated)
• Sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase III, multicenter, randomized, double-masked, Active-controlled design. The aims to confirm previous findings of the efficacy and safety of CsA-PG Ophthalmic Gel by comparing it to CsA Ophthalmic Gel for treating dry eye symptoms.

Detailed description

396 subjects will be enrolled (198 in each treatment group). Subject selection will be conducted during a 14-day run-in period before randomization. After the screening, subjects will receive lubricant eye drops (Refresh Tears®, Carboxymethylcellulose Sodium (0.5%)) treatment bilaterally BID for 14 days. Eligible subjects will be randomized (1:1) and receive the experimental drug or control drug , administered bilaterally once daily for 84 days.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	CsA-PG Ophthalmic Gel	Administer to eyes
DRUG	CsA Ophthalmic Gel	Administer to eyes

Timeline

• Start date: 2025-05-20
• Primary completion: 2025-10-20
• Completion: 2025-11-15
• First posted: 2025-04-24
• Last updated: 2025-04-29