Study of OT-101 in Treating Myopia

Myopia, Progressive Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04770610
• Other study ID #: OT_101_001
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 1, 2021
• Est. completion date: April 2027

Study information

• Verified date: August 2023
• Source: Ocumension (Hong Kong) Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 678
• Est. completion date: April 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 15 Years

Eligibility

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;

Related Conditions & MeSH terms

• Myopia
• Myopia, Degenerative
• Myopia, Progressive

Intervention

Drug:
• OT-101 Ophthalmic Solution
Atropine 0.01%
• Vehicle
Investigational Product minus active ingredient

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Colorado Vision Institute	Colorado Springs	Colorado
United States	Scott & Christie and Associates	Cranberry Township	Pennsylvania
United States	Pediatric Ophthalmology of Erie, Inc	Erie	Pennsylvania
United States	Eye Center of Northern Colorado, PC	Fort Collins	Colorado
United States	Family Focus	Gainesville	Florida
United States	Indiana University Health Physicians Pediatric Ophthalmology	Indianapolis	Indiana
United States	Pediatric Eye Consultants of North Florida	Jacksonville	Florida
United States	Total Eye Care, P.A.	Memphis	Tennessee
United States	Pure Ophthalmic Research	Mint Hill	North Carolina
United States	UPMC Children's Hospital	Pittsburgh	Pennsylvania
United States	Kids Eye Care of Maryland	Rockville	Maryland
United States	San Antonio Eye Center	San Antonio	Texas
United States	CORE, Inc.	Shelby	North Carolina
United States	Comprehensive Eye Care, Ltd.	Washington	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Ocumension (Hong Kong) Limited	ORA, Inc., Statistics & Data Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in spherical equivalent (D) in the study eye as assessed by cycloplegic autorefraction	Efficacy of OT-101 Ophthalmic Solution	Baseline to Month 36
Secondary	Change in study eye axial length as measured by cycloplegic biometry (a standardized device will be selected for this study)	Efficacy of OT-101 Ophthalmic Solution	Baseline to Month 36