Status:
ACTIVE_NOT_RECRUITING
Study of OT-101 in Treating Myopia
Lead Sponsor:
Ocumension (Hong Kong) Limited
Collaborating Sponsors:
ORA, Inc.
Statistics & Data Corporation
Conditions:
Myopia, Progressive
Eligibility:
All Genders
3-15 years
Phase:
PHASE3
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 treatm...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
678 Patients enrolled
Trial Details
Trial ID
NCT04770610
Start Date
April 1 2021
End Date
April 1 2027
Last Update
August 8 2023
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Colorado Vision Institute
Colorado Springs, Colorado, United States, 80907
2
Eye Center of Northern Colorado, PC
Fort Collins, Colorado, United States, 80528
3
Family Focus
Gainesville, Florida, United States, 32607
4
Pediatric Eye Consultants of North Florida
Jacksonville, Florida, United States, 32202