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

This is an interventional treatment trial for Myopia Read More

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.