Actively Recruiting
A Study of the Efficacy and Safety of Cyclosporin Ophthalmic Gel in Subjects With Moderate to Severe Dry Eye Disease
Led by Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. · Updated on 2025-07-28
360
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicenter, randomized, double-blind, placebo-controlled, superiority design Phase III clinical trial. The primary objective is to evaluate the efficacy and safety of cyclosporine ophthalmic gel versus placebo in the treatment of moderate to severe dry eye for 84 days.
CONDITIONS
Official Title
A Study of the Efficacy and Safety of Cyclosporin Ophthalmic Gel in Subjects With Moderate to Severe Dry Eye Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older, male or female
- Experiencing ocular dryness in both eyes for at least 6 months
- Eye dryness score of 40 or higher at screening visits
- Ocular Surface Disease Index score of 13 or higher at screening visits
- Total corneal fluorescein staining score of 2 or more in either eye and at least 1 in one region
- Schirmer I test result of 5 mm or less in 5 minutes in either eye
- Diagnosed with moderate or severe dry eye in both eyes, defined by specific corneal damage and staining criteria
You will not qualify if you...
- Severe dry eye needing surgical treatment
- Systemic retinoid use within 12 months before screening
- Intraocular surgery within 12 months before screening or planned during study
- Eyelid surgery within 6 months before screening
- Permanent lacrimal duct embolization or temporary embolization within 6 months before screening
- Dry eye related to surgery
- Wearing corneal contact lenses within 3 months before screening
- Use of cyclosporine eye or systemic preparations within 1 month before screening
- Use of lifitegrast or tacrolimus eye drops within 1 month before screening
- Dry eye caused by scarring or severe conjunctival damage
- Significant eyelid margin inflammation or meibomian gland dysfunction affecting study outcomes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Xiamen Eye Center of Xiamen University
Xiamen, Fujian, China
Actively Recruiting
Research Team
Z
Zuguo Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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