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ACTIVE NOT RECRUITING
NCT04770610
PHASE3

Study of OT-101 in Treating Myopia

Sponsor: Ocumension (Hong Kong) Limited

View on ClinicalTrials.gov

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

Interventions

DRUG

OT-101 Ophthalmic Solution

Atropine 0.01%

DRUG

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