A Multicenter, Randomized, Double-Masked, Placebo-Controlled Pilot Study to Evaluate the Efficacy and Safety of ZOC2017217 in Subjects With Age-Related Cataract
Part of paid clinical trials in Scottsdale, Arizona.
- Sponsor
- Ocusun Ophthalmic Pharmaceutical (Guangzhou) Co., Ltd.
- Study ID
- NCT07395986
- Phase
- PHASE2
- Status
- Enrolling By Invitation
Conditions
- Age Related Cataracts
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- 0.4% ZOC2017217 — DRUGActive Investigational Product
- Control — DRUGControl
Study Details
This is a multicenter, randomized, double-masked, placebo-controlled pilot study conducted in the United States (US) in subjects with age-related cataract in one or both eyes. Approximately 40 subjects with age-related cataract will be stratified by race and Best Corrected Distance Visual Acuity (BCDVA) and randomized (1:1) to active investigational product (IP) or placebo. Subjects will administer their assigned IP in the qualifying eye(s) two times a day (BID) for 24 weeks before being exited from the study. Subjects with new or ongoing ocular adverse events (AEs) at the time of planned study exit will be asked to return 2 weeks later for a safety follow-up evaluation.
Key Dates
- Start date
- Feb 10, 2026
- Status verified
- Jun 2026
- Primary completion
- Mar 31, 2027
- Completion
- May 31, 2027
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: ControlDrug with no active ingredients
- Experimental: ActiveZOC2017217
Primary Outcome Measure
BCDVA [ Time Frame: Baseline as compared to Weeks 4, 12, and 24. ]
Locations (21)
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