Study of OT-101 in Treating Myopia

Phase 3Active Not RecruitingNCT04770610

Ocumension (Hong Kong) Limited678 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

678

Conditions

Myopia, Progressive

Interventions

OT-101 Ophthalmic SolutionDRUG

Atropine 0.01%

VehicleDRUG

Investigational Product minus active ingredient

Eligibility

Sex: ALLMin age: 3 YearsMax age: 15 Years

Medical Language ↔ Plain English

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;

Locations (15)

Colorado Vision Institute

Colorado Springs, Colorado, United States

Eye Center of Northern Colorado, PC

Fort Collins, Colorado, United States

Outcomes

Primary Outcomes

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

Time frame: At month 36

Secondary Outcomes

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

Efficacy of OT-101 Ophthalmic Solution

Time frame: Baseline to Month 36

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

Time frame: Baseline to Month 36

Data from ClinicalTrials.gov

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