Microdosed Atropine 0.1% and 0.01% Ophthalmic Solutions for Reduction of Pediatric Myopia Progression

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the progression of myopia in participants using microdosed atropine 0.01%, atropine 0.1%, or placebo ophthalmic solution. Eligible subjects will administer study medication daily in each eye for 48 months. Efficacy and safety assessments will be performed at visits scheduled for 1, 6, 12, 18, 24, 30 and 36 months after initiation of medication use. Subjects will be re-randomized at the 36 month visit, then followed at 6 month intervals for an additional year.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eyenovia Inc.
• Treatments: Atropine; Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Refractive error by cycloplegic autorefraction: myopia -1.00 D to -6.00 D in both eyes; astigmatism ≤ 1.50 D in both eyes; anisometropia < 1.50 D.

• Best-corrected distance visual acuity in current correction of 0.2 logMAR or better with interocular difference ≤ 0.1 logMAR.

• Refractive correction for each eye meets the following criteria: myopia within ± 0.50 D of the manifest refraction at the Screening Visit; cylinder power within ± 0.50 D of the manifest refraction at the Screening Visit; when cylinder power is < 1.00 D, axis within ± 15 degrees of the manifest refraction; when cylinder power is ≥ 1.00 D, axis within ± 5 degrees of the manifest refraction.

Exclusion Criteria:

• Current or previous myopia treatment with non-study atropine, pirenzepine or other topical anti-muscarinic agent.

• Current use of bifocals, progressive-addition lenses, or multifocal soft contact lenses.

• Use of rigid gas permeable lenses, including orthokeratology lenses within 90 days of Screening.

• Known atropine allergy.

• Abnormality of the cornea, lens, central retina, iris or ciliary body.

• Current or prior history of manifest strabismus, amblyopia, or nystagmus.

• Prior eyelid, strabismus, intraocular, or refractive surgery.

• Intraocular pressure > 26 mmHg.

• History of premature birth by parent's report.

• Inability to perform protocol-prescribed testing due to preexisting neurological diagnoses, genetic syndrome, or other issues.

• Medical conditions predisposing patient to degenerative myopia, abnormal ocular refractive anatomy, and/or any history of intraocular surgery.

• Any systemic disease or condition that may affect visual function or development such as diabetes mellitus.

• Any ocular inflammation or external ocular inflammation within 30 days of Screening.

• History of punctal occlusion.

• Heterochromia.

• Lid squeezers.

• Participation in any study of an investigational, interventional product within 30 days prior to Screening Visit.

• Immediate family member of study staff designed to perform study evaluations or procedures.

• Pregnancy, or if sexually active, unwillingness to use an acceptable form of contraception during the study.

• Presence of a severe/serious ocular condition or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up.