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A Multicenter, Randomized, Double-Masked, Placebo-Controlled Pilot Study to Evaluate the Efficacy and Safety of ZOC2017217 in Subjects With Age-Related Cataract
Sponsor: Ocusun Ophthalmic Pharmaceutical (Guangzhou) Co., Ltd.
Summary
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 both eyes, except as noted below, 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. The study eye will be the qualified eye that meets study eligibility criteria. Data from the study eye will be used for the purposes of efficacy analyses. Both eyes will receive treatment, except in subjects who have previously undergone cataract surgery in the non-study eye or whose non-study eye, in the opinion of the Investigator, is not suitable for treatment with the IP due to safety or another concern.
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-02-10
Completion Date
2027-05
Last Updated
2026-07-09
Healthy Volunteers
No
Conditions
Interventions
0.4% ZOC2017217
Active Investigational Product
Control
Control
Locations (21)
Cornea and Cataract Consultants of Arizona
Scottsdale, Arizona, United States
Catalina Eye
Tucson, Arizona, United States
Global Research Management
Glendale, California, United States
Inland Eye Specialists
Hemet, California, United States
United Medical Research Institute
Inglewood, California, United States
North Bay Eye Associates, Inc.
Petaluma, California, United States
East West Eye Institute - Torrance
Torrance, California, United States
ICON Eye Care
Grand Junction, Colorado, United States
Advanced Vision Research Institute
Longmont, Colorado, United States
Rand Eye Institute
Deerfield Beach, Florida, United States
Levenson Eye Associates
Jacksonville, Florida, United States
Clayton Eye Clinical Research, LLC
Morrow, Georgia, United States
Springfield Clinic
Springfield, Illinois, United States
Oculus Research - Cary
Cary, North Carolina, United States
Bergstrom Eye Research
Fargo, North Dakota, United States
Cincinnati Eye Institute - Blue Ash
Blue Ash, Ohio, United States
Verum Research
Eugene, Oregon, United States
Erie Retina Research
Erie, Pennsylvania, United States
Valley Retina Institute P.A.
Laredo, Texas, United States
Valley Retina Institute P.A.
McAllen, Texas, United States
R and R Eye Research, LLC
San Antonio, Texas, United States