Condition: Age Related Cataracts · Sponsor: Ocusun Ophthalmic Pharmaceutical (Guangzhou) Co., Ltd.
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.
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
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| Cornea and Cataract Consultants of Arizona | Scottsdale, Arizona, United States | Terminated |
| Catalina Eye | Tucson, Arizona, United States | Recruiting |
| Global Research Management | Glendale, California, United States | Recruiting |
| Inland Eye Specialists | Hemet, California, United States | Recruiting |
| United Medical Research Institute | Inglewood, California, United States | Recruiting |
| North Bay Eye Associates, Inc. | Petaluma, California, United States | Recruiting |
| East West Eye Institute - Torrance | Torrance, California, United States | Recruiting |
| ICON Eye Care | Grand Junction, Colorado, United States | Terminated |
| Advanced Vision Research Institute | Longmont, Colorado, United States | Recruiting |
| Rand Eye Institute | Deerfield Beach, Florida, United States | Recruiting |
| Levenson Eye Associates | Jacksonville, Florida, United States | Recruiting |
| Clayton Eye Clinical Research, LLC | Morrow, Georgia, United States | Recruiting |
+ 9 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07395986