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DOLPHIN


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
Therapeutic Area Myopia
Principal Investigator Vicki Chen, MD
Min Age 3 Years
Max Age 15 Years
Gender Any
Contact Sara Galinko
617-636-5263
sgalinko@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04770610

Overview

This study will last approximately 4 years. Screening will last for approximately 2 weeks. Stage 1, where subjects will be randomized in a 2:1 ratio to OT-101 Ophthalmic Solution or placebo, will last approximately 3 years. Stage 2, where subjects previously assigned to OT-101 Ophthalmic Solution will be re-randomized to either continue with OT-101 Ophthalmic Solution or switch to placebo and subjects previously assigned to placebo will continue with placebo, will last approximately 1 year. Subjects will be asked to undergo visual acuity testing and intraocular examinations at visits every 6 months. Ocular imaging will be performed on a yearly basis.

Study Details

Inclusion Criteria

  1. Have refractive error by cycloplegic autorefraction at baseline (Visit 1) in the study eye of:
    1. Myopia between -1.00 D and -6.00 D, inclusive, of spherical equivalent
    2. Astigmatism less than or equal to 1.50 DC
  2. Have anisometropia ≤ 1.0 D at Visit 1
  3. Have a best-corrected distance visual acuity (BCVA) of ≤ 0.2 logarithm of the minimum angle of resolution (logMAR) (approximately Snellen 20/30) in each eye as measured using an ETDRS chart (or LeaChart for subjects who do not know the alphabet) at Visit 1 and Visit 2

Exclusion Criteria

  1. Have known contraindications or sensitivity to atropine, the study medications, or their components;
  2. Have clinically significant abnormal findings on slit lamp biomicroscopy exam (E.g. cataract) which may impact best corrected visual acuity measures in either eye documented or a known history of a clinically significant slit lamp findings in either eye
  3. Have a clinically significant abnormal findings on indirect dilated fundoscopy exam in either eye documented or a known history of a clinically significant retinal finding in either eye

Study Requirements

Subjects will be asked to attend 11 visits onsite and completed 9 scheduled phone calls during the duration of the study. Visits will consist of various eye exams, including visual acuity and intraocular examination (cornea and retina). Families will be asked to return onsite on a monthly basis to obtain a new 4 week supply of masked study IP.