Myopia, Progressive
Conditions
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.
Interventions
DRUGOT-101 Ophthalmic Solution
Atropine 0.01%
DRUGVehicle
Investigational Product minus active ingredient
Sponsors
ORA, Inc.
Statistics & Data Corporation
Ocumension (Hong Kong) Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to 15 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed