Study of OT-101 in Treating Myopia
K
Kathryn Haider, MD
Primary Investigator
Not Recruiting
3 years - 15 years
All
Phase
3
678 participants needed
1 Location
Brief description of study
This is a phase III, randomized, double-masked, placebo-controlled, parallel-group,ulticenter safety, tolerability, and efficacy study of atropine sulfate 0.01% (OT-101) as anvestigational treatment for myopia in pediatric subjects
Detailed description of study
This is a phase III, randomized, double-masked, placebo-controlled, parallel-group,ulti-center study to evaluate the safety tolerability and efficacy of OT-101 (Atropine.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 bed 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-101hthalmic Solution: Placebo. Subjects will be dosed with one drop of study treatment per eyedaily at bedtime for 3 years. In stage 2, subjects will be re-randomization 1:1 willur at Visit 9 (Month 36). At re-randomization, subjects who had been assigned to OT-101hthalmic Solution will be randomized in a 1:1 ratio to continue on OT-101 Ophthalmicution or switch to placebo. Subjects who had been assigned to placebo will continue withbo.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Myopia, Progressive
-
Age: 3 years - 15 years
-
Gender: All
Inclusion Criteria:
- Have refractive error by cycloplegic autorefraction at baseline (Visit 1) in the studyye 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 ulcerativekeratitis, scleritis) in either eye;
- Have undergone any myopia control treatment including orthokeratology, rigidgas-permeable contact lenses, bifocal contact lenses, progressive addition spectacleher lenses to reduce myopia progression in the previous 6 months. Myopiche form of single-vision eyeglasses and/or single-vision soft contactwed;
- Have undergone any form of refractive eye surgery including incisional keratotomy,hotorefractive keratectomy [PRK], laser in situ keratomileusis [LASIK],d sub- epithelial keratectomy [LASEK]), corneal inlay procedures,ductive keratoplasty, small incision lenticule extraction (SMILE), cataracty form of intraocular lens implantation;
Updated on
01 Aug 2024.
Study ID: OT_101_001, OPTH-OCUMENSION-OT-101, 10821
