NCT04770610

Study of OT-101 in Treating Myopia

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 678 (estimated)
• Sponsor: Ocumension (Hong Kong) Limited · Academic / Other
• Sex: All
• Age: 3 Years – 15 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a phase III, randomized, double-masked, placebo-controlled, parallel-group, multi-center study to evaluate the safety tolerability and efficacy of OT-101 (Atropine 0.01%) Ophthalmic Solution in treating the progression of myopia in pediatric subjects that will enroll approximately 678 pediatric subjects with myopia in total. Subjects will be stratified by age and refractive error. This study consists of 11 visits over the course of approximately 4 years and can be broken down in the 3 stages: Screening (Days -14 to -1), Stage 1 (Day 1 to Year 3), and Stage 2 (Year 3 to Year 4). In stage 1, subjects will be randomized in a 2:1 manner to OT-101 Ophthalmic Solution: Placebo. Subjects will be dosed with one drop of study treatment per eye once daily at bedtime for 3 years. In stage 2, subjects will be re-randomization 1:1 will occur at Visit 9 (Month 36). At re-randomization, subjects who had been assigned to OT-101 Ophthalmic Solution will be randomized in a 1:1 ratio to continue on OT-101 Ophthalmic Solution or switch to placebo. Subjects who had been assigned to placebo will continue with placebo.

Conditions

• Myopia, Progressive

Interventions

Type	Name	Description
DRUG	OT-101 Ophthalmic Solution	Atropine 0.01%
DRUG	Vehicle	Investigational Product minus active ingredient

Timeline

• Start date: 2021-04-01
• Primary completion: 2027-03-01
• Completion: 2027-04-01
• First posted: 2021-02-25
• Last updated: 2023-08-08

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study