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Study of OT-101 in Treating Myopia

NCT04770610 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 678

Last updated 2023-08-08

No results posted yet for this study

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

Conditions

  • Myopia, Progressive

Interventions

DRUG

OT-101 Ophthalmic Solution

Atropine 0.01%

DRUG

Vehicle

Investigational Product minus active ingredient

Sponsors & Collaborators

  • ORA, Inc.

    collaborator INDUSTRY

  • Statistics & Data Corporation

    collaborator INDUSTRY

  • Ocumension (Hong Kong) Limited

    lead OTHER

Principal Investigators

  • Keith Lane · ORA, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2027-03-31
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04770610 on ClinicalTrials.gov