Study of OT-101 in Treating Myopia
Primary Purpose
Myopia, Progressive
Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
OT-101 Ophthalmic Solution
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Myopia, Progressive
Eligibility Criteria
Inclusion Criteria:
Have refractive error by cycloplegic autorefraction at baseline (Visit 1) in the study eye of:
- myopia greater or equal to -1.00D of spherical equivalent
- astigmatism less than or equal to 1.50DC
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;
Sites / Locations
- Colorado Vision Institute
- Eye Center of Northern Colorado, PC
- Family Focus
- Pediatric Eye Consultants of North Florida
- Indiana University Health Physicians Pediatric Ophthalmology
- Kids Eye Care of Maryland
- Comprehensive Eye Care, Ltd.
- Pure Ophthalmic Research
- CORE, Inc.
- University Hospitals Cleveland Medical Center
- Scott & Christie and Associates
- Pediatric Ophthalmology of Erie, Inc
- UPMC Children's Hospital
- Total Eye Care, P.A.
- San Antonio Eye Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
OT-101 alone
OT-101 plus vehicle
Vehicle
Arm Description
Atropine Sulfate 0.01% Ophthalmic Solution through year 4
Atropine Sulfate 0.01% Ophthalmic Solution through year 3 followed by vehicle for 1 year
Vehicle (Investigational Product minus active ingredient) through year 4
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change in spherical equivalent (D) in the study eye as assessed by cycloplegic autorefraction
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)
Efficacy of OT-101 Ophthalmic Solution
Full Information
NCT ID
NCT04770610
First Posted
February 22, 2021
Last Updated
August 7, 2023
Sponsor
Ocumension (Hong Kong) Limited
Collaborators
ORA, Inc., Statistics & Data Corporation
1. Study Identification
Unique Protocol Identification Number
NCT04770610
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
March 2027 (Anticipated)
Study Completion Date
April 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ocumension (Hong Kong) Limited
Collaborators
ORA, Inc., Statistics & Data Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Progressive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
678 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
OT-101 alone
Arm Type
Experimental
Arm Description
Atropine Sulfate 0.01% Ophthalmic Solution through year 4
Arm Title
OT-101 plus vehicle
Arm Type
Experimental
Arm Description
Atropine Sulfate 0.01% Ophthalmic Solution through year 3 followed by vehicle for 1 year
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle (Investigational Product minus active ingredient) through year 4
Intervention Type
Drug
Intervention Name(s)
OT-101 Ophthalmic Solution
Other Intervention Name(s)
Investigational Product
Intervention Description
Atropine 0.01%
Intervention Type
Drug
Intervention Name(s)
Vehicle
Other Intervention Name(s)
Placebo
Intervention Description
Investigational Product minus active ingredient
Primary Outcome Measure Information:
Title
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.
Description
Efficacy of OT-101 Ophthalmic Solution
Time Frame
At month 36
Secondary Outcome Measure Information:
Title
Change in spherical equivalent (D) in the study eye as assessed by cycloplegic autorefraction
Description
Efficacy of OT-101 Ophthalmic Solution
Time Frame
Baseline to Month 36
Title
Change in study eye axial length as measured by cycloplegic biometry (a standardized device will be selected for this study)
Description
Efficacy of OT-101 Ophthalmic Solution
Time Frame
Baseline to Month 36
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have refractive error by cycloplegic autorefraction at baseline (Visit 1) in the study eye of:
myopia greater or equal to -1.00D of spherical equivalent
astigmatism less than or equal to 1.50DC
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith Lane
Organizational Affiliation
ORA, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Colorado Vision Institute
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Eye Center of Northern Colorado, PC
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Family Focus
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Pediatric Eye Consultants of North Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32202
Country
United States
Facility Name
Indiana University Health Physicians Pediatric Ophthalmology
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Kids Eye Care of Maryland
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Comprehensive Eye Care, Ltd.
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
Pure Ophthalmic Research
City
Mint Hill
State/Province
North Carolina
ZIP/Postal Code
28227
Country
United States
Facility Name
CORE, Inc.
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Scott & Christie and Associates
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Pediatric Ophthalmology of Erie, Inc
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16501
Country
United States
Facility Name
UPMC Children's Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Total Eye Care, P.A.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
San Antonio Eye Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Study of OT-101 in Treating Myopia
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