Clinical trial NCT04770610: Study of OT-101 in Treating Myopia
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Myopia, Progressive
Lead sponsor: Ocumension (Hong Kong) Limited
Sponsor class: OTHER
Collaborators: name: ORA, Inc.
name: Statistics & Data Corporation
First posted: 2021-02-25
Enrollment: 678
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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;

Primary outcomes:
measure: 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.
timeFrame: At month 36
Secondary outcomes:
measure: Change in spherical equivalent (D) in the study eye as assessed by cycloplegic autorefraction
timeFrame: Baseline to Month 36
measure: Change in study eye axial length as measured by cycloplegic biometry (a standardized device will be selected for this study)
timeFrame: Baseline to Month 36
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Colorado Vision Institute
state: Colorado
city: Fort Collins
country: United States
facility: Eye Center of Northern Colorado, PC
state: Colorado
city: Gainesville
country: United States
facility: Family Focus
state: Florida
city: Jacksonville
country: United States
facility: Pediatric Eye Consultants of North Florida
state: Florida
city: Indianapolis
country: United States
facility: Indiana University Health Physicians Pediatric Ophthalmology
state: Indiana
city: Rockville
country: United States
facility: Kids Eye Care of Maryland
state: Maryland
city: Washington
country: United States
facility: Comprehensive Eye Care, Ltd.
state: Missouri
city: Mint Hill
country: United States
facility: Pure Ophthalmic Research
state: North Carolina
city: Shelby
country: United States
facility: CORE, Inc.
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cranberry Township
country: United States
facility: Scott & Christie and Associates
state: Pennsylvania
city: Erie
country: United States
facility: Pediatric Ophthalmology of Erie, Inc
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital
state: Pennsylvania
city: Memphis
country: United States
facility: Total Eye Care, P.A.
state: Tennessee
city: San Antonio
country: United States
facility: San Antonio Eye Center
state: Texas
Study officials:
affiliation: ORA, Inc.
name: Keith Lane
role: STUDY_DIRECTOR
References: