A Phase 3 Study of the Safety and Efficacy of 2% Pilocarpine Ophthalmic Spray Administered With the Optejet® Microdose Dispenser for Temporary Improvement of Near Vision in Adults With Presbyopia

EYN-PRS-PI-32

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.

2021-11-03

2022-09-20

2022-09-20

Completed

Early phase I

145

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 145, 'type': 'ACTUAL'}}

2023-09-11