Study of OT-101 in Treating Myopia

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Myopia, Progressive
• Intervention / Treatment: Drug: OT-101 Ophthalmic Solution; Drug: Vehicle

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.

• Study Type: Interventional
• Enrollment (Estimated): 678
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Prateek Gajwani; Phone Number: 1-443-813-6590; Email: pgajwani@oraclinical.com

Study Locations

• United States
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Colorado Vision Institute
    • Fort Collins, Colorado, United States, 80528
      • Eye Center of Northern Colorado, PC
  • Florida
    • Gainesville, Florida, United States, 32607
      • Family Focus
    • Jacksonville, Florida, United States, 32202
      • Pediatric Eye Consultants of North Florida
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health Physicians Pediatric Ophthalmology
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Kids Eye Care of Maryland
  • Missouri
    • Washington, Missouri, United States, 63090
      • Comprehensive Eye Care, Ltd.
  • North Carolina
    • Mint Hill, North Carolina, United States, 28227
      • Pure Ophthalmic Research
    • Shelby, North Carolina, United States, 28150
      • CORE, Inc.
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Scott & Christie and Associates
    • Erie, Pennsylvania, United States, 16501
      • Pediatric Ophthalmology of Erie, Inc
    • Pittsburgh, Pennsylvania, United States, 15224
      • UPMC Children's Hospital
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care, P.A.
  • Texas
    • San Antonio, Texas, United States, 78215
      • San Antonio Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 13 years (Child)
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OT-101 alone; Atropine Sulfate 0.01% Ophthalmic Solution through year 4	Drug: OT-101 Ophthalmic Solution; Atropine 0.01%; Other Names: Investigational Product
Experimental: OT-101 plus vehicle; Atropine Sulfate 0.01% Ophthalmic Solution through year 3 followed by vehicle for 1 year	Drug: OT-101 Ophthalmic Solution; Atropine 0.01%; Other Names: Investigational Product; Drug: Vehicle; Investigational Product minus active ingredient; Other Names: Placebo
Placebo Comparator: Vehicle; Vehicle (Investigational Product minus active ingredient) through year 4	Drug: Vehicle; Investigational Product minus active ingredient; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At month 36

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in spherical equivalent (D) in the study eye as assessed by cycloplegic autorefraction	Efficacy of OT-101 Ophthalmic Solution	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	Baseline to Month 36

Collaborators and Investigators

• Sponsor: Ocumension (Hong Kong) Limited
• Collaborators: ORA, Inc.; Statistics & Data Corporation
• Investigators: Study Director: Keith Lane, ORA, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 25, 2021

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Myopia, Degenerative; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: OT_101_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No