Safety & Efficacy of Pilocarpine Ophthalmic Spray for Temporary Improvement of Near Vision in Presbyopic Adults

• Status: Recruiting
• Trial end date: 2022-04-30
• Target enrollment: 0
• Participant gender: All

Summary

Volunteer participants are evaluated for eligibility during a Screening Visit; those meeting study inclusion/exclusion criteria are scheduled for 2 treatment visits. At each treatment visit, 1 of the 2 study treatments is self-administered to both eyes. Afterwards, efficacy and safety assessments are performed over a 3-hour period.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eyenovia Inc.
• Treatments: Pilocarpine

Criteria

Primary Inclusion Criteria:

• Poor near vision impacting daily living that requires near correction

• Best-corrected distance visual acuity (BCDVA) of 0.0 logMar or better

• Manifest refraction spherical equivalent ≥ -2.00 Diopters (D) and ≤ +2.00 D

• Monocular DCNVA between 0.4 and 0.7 logMAR, inclusive

• In need of near addition power < +2.00 D to achieve BCNVA of 0.0 logMAR

Primary Exclusion Criteria:

• Diagnosis of glaucoma or ocular hypertension

• Narrow iridocorneal angles

• History of intraocular surgery, refractive surgery, laser treatment, or iris surgery

• Clinically significant abnormality of cornea, lens, retina, ciliary body, or iris

• Presence/history of a severe/serious ocular condition or any other unstable medical condition

• Presence or history of manifest strabismus, amblyopia, or nystagmus

• Current active eye disease for which topical or systemic ophthalmic medication is necessary, except for dry eye syndrome managed using artificial tears

• Clinically significant external ocular inflammation within 30 days of Screening Visit

• Current use or history of rigid gas permeable (RGP) contact lens use within 30 days of Screening Visit

• Known pilocarpine allergy or contraindication to use of pilocarpine

• Presence or history of congenital heart anomaly, valve disease, or other cardiac disease

• Disabling arthritis or limited motor coordination that would limit the subject's ability to self-administer study solution using the Optejet