Study of OT-101 in Treating Myopia

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Myopia, Progressive

In brief

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

Key facts

Study ID

NCT04770610

Run by

Ocumension (Hong Kong) Limited

People needed

678

Starts

2021-04-01

Expected to finish

2027-04-01

Last updated by the study team

2023-08-08

Who can join

Age: 3 and older, up to 15. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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;

Where it is running

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

Full record on ClinicalTrials.gov

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