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Study of OT-101 in Treating Myopia
Sponsor: Ocumension (Hong Kong) Limited
Summary
This is a phase III, randomized, double-masked, placebo-controlled, parallel-group, multicenter safety, tolerability, and efficacy study of atropine sulfate 0.01% (OT-101) as an investigational treatment for myopia in pediatric subjects
Official title: A Phase III, Randomized, Double-masked, Placebo-controlled, Parallel-group, Multicenter Study of the Safety and Efficacy of OT-101 (Atropine Sulfate 0.01%) in Treating the Progression of Myopia in Pediatric Subjects
Key Details
Gender
All
Age Range
3 Years - 15 Years
Study Type
INTERVENTIONAL
Enrollment
678
Start Date
2021-04-01
Completion Date
2027-04
Last Updated
2023-08-08
Healthy Volunteers
No
Conditions
Interventions
OT-101 Ophthalmic Solution
Atropine 0.01%
Vehicle
Investigational Product minus active ingredient
Locations (15)
Colorado Vision Institute
Colorado Springs, Colorado, United States
Eye Center of Northern Colorado, PC
Fort Collins, Colorado, United States
Family Focus
Gainesville, Florida, United States
Pediatric Eye Consultants of North Florida
Jacksonville, Florida, United States
Indiana University Health Physicians Pediatric Ophthalmology
Indianapolis, Indiana, United States
Kids Eye Care of Maryland
Rockville, Maryland, United States
Comprehensive Eye Care, Ltd.
Washington, Missouri, United States
Pure Ophthalmic Research
Mint Hill, North Carolina, United States
CORE, Inc.
Shelby, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Scott & Christie and Associates
Cranberry Township, Pennsylvania, United States
Pediatric Ophthalmology of Erie, Inc
Erie, Pennsylvania, United States
UPMC Children's Hospital
Pittsburgh, Pennsylvania, United States
Total Eye Care, P.A.
Memphis, Tennessee, United States
San Antonio Eye Center
San Antonio, Texas, United States