Study of OT-101 in Treating Myopia
- Conditions
- Myopia, Progressive
- Interventions
- Drug: OT-101 Ophthalmic SolutionDrug: Vehicle
- Registration Number
- NCT04770610
- Lead Sponsor
- Ocumension (Hong Kong) Limited
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 678
-
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;
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OT-101 plus vehicle OT-101 Ophthalmic Solution Atropine Sulfate 0.01% Ophthalmic Solution through year 3 followed by vehicle for 1 year Vehicle Vehicle Vehicle (Investigational Product minus active ingredient) through year 4 OT-101 alone OT-101 Ophthalmic Solution Atropine Sulfate 0.01% Ophthalmic Solution through year 4 OT-101 plus vehicle Vehicle Atropine Sulfate 0.01% Ophthalmic Solution through year 3 followed by vehicle for 1 year
- Primary Outcome Measures
Name Time Method 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. At month 36 Efficacy of OT-101 Ophthalmic Solution
- Secondary Outcome Measures
Name Time Method Change in spherical equivalent (D) in the study eye as assessed by cycloplegic autorefraction Baseline to Month 36 Efficacy of OT-101 Ophthalmic Solution
Change in study eye axial length as measured by cycloplegic biometry (a standardized device will be selected for this study) Baseline to Month 36 Efficacy of OT-101 Ophthalmic Solution
Trial Locations
- Locations (15)
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
Scroll for more (5 remaining)Colorado Vision Institute🇺🇸Colorado Springs, Colorado, United States