Study of OT-101 in Treating Myopia

NCT04770610 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: OT_101_001
• Study Type: interventional
• Target: 678
• Locations: 1 country
• Sites: 15

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

Conditions

Myopia, Progressive

Outcome Measures

Primary Outcomes (1)

• Percentage of study eyes with a -0.75D of progressive myopia defined as an increase in spherical equivalent of -0.75D or greater as assessed by cycloplegic autorefraction.

  Efficacy of OT-101 Ophthalmic Solution

  At month 36

Secondary Outcomes (2)

• Change in spherical equivalent (D) in the study eye as assessed by cycloplegic autorefraction

  Baseline to Month 36

• Change in study eye axial length as measured by cycloplegic biometry (a standardized device will be selected for this study)

  Baseline to Month 36

Study Arms (3)

OT-101 alone

EXPERIMENTAL

Atropine Sulfate 0.01% Ophthalmic Solution through year 4

Drug: OT-101 Ophthalmic Solution

OT-101 plus vehicle

EXPERIMENTAL

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

Drug: OT-101 Ophthalmic Solution; Drug: Vehicle

Vehicle

PLACEBO COMPARATOR

Vehicle (Investigational Product minus active ingredient) through year 4

Drug: Vehicle

Interventions

OT-101 Ophthalmic Solution DRUG

Atropine 0.01%

Also known as: Investigational Product

OT-101 alone; OT-101 plus vehicle

Vehicle DRUG

Investigational Product minus active ingredient

Also known as: Placebo

OT-101 plus vehicle; Vehicle

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Have refractive error by cycloplegic autorefraction at baseline (Visit 1) in the study eye of:
• myopia greater or equal to -1.00D of spherical equivalent
• astigmatism less than or equal to 1.50DC
• progression of at least -0.50D of spherical equivalent in the last 12 months;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Ocumension (Hong Kong) Limited: lead
• ORA, Inc.: collaborator
• Statistics & Data Corporation: collaborator

Study Sites (15)

Colorado Vision Institute

Colorado Springs, Colorado, 80907, United States

Location

Eye Center of Northern Colorado, PC

Fort Collins, Colorado, 80528, United States

Location

Family Focus

Gainesville, Florida, 32607, United States

Location

Pediatric Eye Consultants of North Florida

Jacksonville, Florida, 32202, United States

Location

Indiana University Health Physicians Pediatric Ophthalmology

Indianapolis, Indiana, 46202, United States

Location

Kids Eye Care of Maryland

Rockville, Maryland, 20850, United States

Location

Comprehensive Eye Care, Ltd.

Washington, Missouri, 63090, United States

Location

Pure Ophthalmic Research

Mint Hill, North Carolina, 28227, United States

Location

CORE, Inc.

Shelby, North Carolina, 28150, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Scott & Christie and Associates

Cranberry Township, Pennsylvania, 16066, United States

Location

Pediatric Ophthalmology of Erie, Inc

Erie, Pennsylvania, 16501, United States

Location

UPMC Children's Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

Total Eye Care, P.A.

Memphis, Tennessee, 38119, United States

Location

San Antonio Eye Center

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Conditions

Myopia, Degenerative

Condition Hierarchy (Ancestors)

Myopia; Refractive Errors; Eye Diseases

Study Officials

• Keith Lane

  ORA, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 25, 2021
• Study Start: April 1, 2021
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)