Study of OT-101 in Treating Myopia

NCT ID: NCT04770610

Last Updated: 2023-08-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 678 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2027-04-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

OT-101 alone

Atropine Sulfate 0.01% Ophthalmic Solution through year 4

Group Type: EXPERIMENTAL

OT-101 Ophthalmic Solution

Intervention Type: DRUG

Atropine 0.01%

OT-101 plus vehicle

Atropine Sulfate 0.01% Ophthalmic Solution through year 3 followed by vehicle for 1 year

Group Type: EXPERIMENTAL

OT-101 Ophthalmic Solution

Intervention Type: DRUG

Atropine 0.01%

Vehicle

Intervention Type: DRUG

Investigational Product minus active ingredient

Vehicle

Vehicle (Investigational Product minus active ingredient) through year 4

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: DRUG

Investigational Product minus active ingredient

Interventions

OT-101 Ophthalmic Solution

Atropine 0.01%

Intervention Type: DRUG

Vehicle

Investigational Product minus active ingredient

Intervention Type: DRUG

Other Intervention Names

Investigational Product; Placebo

Eligibility Criteria

Inclusion Criteria

• Have refractive error by cycloplegic autorefraction at baseline (Visit 1) in the study eye of:

1. myopia greater or equal to -1.00D of spherical equivalent

2. astigmatism less than or equal to 1.50DC

3. progression of at least -0.50D of spherical equivalent in the last 12 months;

Exclusion Criteria

• Have active or a history of chronic or recurrent episodes of ocular inflammation (e.g. moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis) in either eye;
• Have undergone any myopia control treatment including orthokeratology, rigid gas-permeable contact lenses, bifocal contact lenses, progressive addition spectacle lenses, or other lenses to reduce myopia progression in the previous 6 months. Myopic correction in the form of single-vision eyeglasses and/or single-vision soft contact lenses are allowed;
• Have undergone any form of refractive eye surgery including incisional keratotomy, photorefractive keratectomy [PRK], laser in situ keratomileusis [LASIK], laser-assisted sub- epithelial keratectomy [LASEK]), corneal inlay procedures, conductive keratoplasty, small incision lenticule extraction (SMILE), cataract extraction, or any form of intraocular lens implantation;

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ORA, Inc.

INDUSTRY

Sponsor Role: collaborator

Statistics & Data Corporation

INDUSTRY

Sponsor Role: collaborator

Ocumension (Hong Kong) Limited

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keith Lane

Role: STUDY_DIRECTOR

ORA, Inc.

Locations

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

Countries

United States

Other Identifiers

OT_101_001

Identifier Type: -

Identifier Source: org_study_id