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Trial record 1 of 2 for:    OT_101_001
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Study of OT-101 in Treating Myopia

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ClinicalTrials.gov Identifier: NCT04770610
Recruitment Status : Recruiting
First Posted : February 25, 2021
Last Update Posted : November 2, 2022
Sponsor:
Collaborators:
ORA, Inc.
Statistics & Data Corporation
Information provided by (Responsible Party):
Ocumension (Hong Kong) Limited

Study Description
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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

Condition or disease Intervention/treatment Phase
Myopia, Progressive Drug: OT-101 Ophthalmic Solution Drug: Vehicle Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 678 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : March 2027
Estimated Study Completion Date : April 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Investigational Product

Drug: Vehicle
Investigational Product minus active ingredient
Other Name: Placebo
Placebo Comparator: Vehicle
Vehicle (Investigational Product minus active ingredient) through year 4
 Drug: Vehicle
Investigational Product minus active ingredient
Other Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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. [ Time Frame: At month 36 ]
    Efficacy of OT-101 Ophthalmic Solution


Secondary Outcome Measures :
  1. Change in spherical equivalent (D) in the study eye as assessed by cycloplegic autorefraction [ Time Frame: Baseline to Month 36 ]
    Efficacy of OT-101 Ophthalmic Solution

  2. Change in study eye axial length as measured by cycloplegic biometry (a standardized device will be selected for this study) [ Time Frame: Baseline to Month 36 ]
    Efficacy of OT-101 Ophthalmic Solution


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04770610


Contacts
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Contact: Prateek Gajwani 1-443-813-6590 pgajwani@oraclinical.com

Locations
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Sponsors and Collaborators
Ocumension (Hong Kong) Limited
ORA, Inc.
Statistics & Data Corporation
Investigators
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Study Director: Keith Lane ORA, Inc.
More Information
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Responsible Party: Ocumension (Hong Kong) Limited
ClinicalTrials.gov Identifier: NCT04770610    
Other Study ID Numbers: OT_101_001
First Posted: February 25, 2021    Key Record Dates
Last Update Posted: November 2, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myopia
Myopia, Degenerative
Refractive Errors
 Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions