Study of OT-101 in Treating Myopia

Ocumension

Status and phase: Active, not recruiting; Phase 3

Conditions: Myopia, Progressive

Treatments: Drug: OT-101 Ophthalmic Solution; Drug: Vehicle

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04770610

OT_101_001

Details and patient eligibility

About

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

Full 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.

Enrollment: 678 estimated patients

Sex: All

Ages: 3 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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678 participants in 3 patient groups, including a placebo group

OT-101 alone

Experimental group

Description:

Atropine Sulfate 0.01% Ophthalmic Solution through year 4

Treatment:

Drug: OT-101 Ophthalmic Solution

OT-101 plus vehicle

Experimental group

Description:

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

Treatment:

Drug: Vehicle

Drug: OT-101 Ophthalmic Solution

Vehicle

Placebo Comparator group

Description:

Vehicle (Investigational Product minus active ingredient) through year 4

Treatment:

Drug: Vehicle