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Active, not recruiting Phase 3 Interventional

Study of OT-101 in Treating Myopia

ClinicalTrials.gov ID: NCT04770610

Public ClinicalTrials.gov record NCT04770610. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 7:19 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT04770610
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Enrollment
678 participants

Conditions and interventions

Eligibility (public fields only)

Age range
3 Years to 15 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2021
Primary completion
Feb 28, 2027
Completion
Mar 31, 2027
Last update posted
Aug 7, 2023

2021 – 2027

United States locations

U.S. sites
15
U.S. states
10
U.S. cities
15
Facility City State ZIP Site status
Colorado Vision Institute Colorado Springs Colorado 80907
Eye Center of Northern Colorado, PC Fort Collins Colorado 80528
Family Focus Gainesville Florida 32607
Pediatric Eye Consultants of North Florida Jacksonville Florida 32202
Indiana University Health Physicians Pediatric Ophthalmology Indianapolis Indiana 46202
Kids Eye Care of Maryland Rockville Maryland 20850
Comprehensive Eye Care, Ltd. Washington Missouri 63090
Pure Ophthalmic Research Mint Hill North Carolina 28227
CORE, Inc. Shelby North Carolina 28150
University Hospitals Cleveland Medical Center Cleveland Ohio 44106
Scott & Christie and Associates Cranberry Township Pennsylvania 16066
Pediatric Ophthalmology of Erie, Inc Erie Pennsylvania 16501
UPMC Children's Hospital Pittsburgh Pennsylvania 15224
Total Eye Care, P.A. Memphis Tennessee 38119
San Antonio Eye Center San Antonio Texas 78215

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04770610, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 7, 2023 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04770610 live on ClinicalTrials.gov.

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