Safety & Efficacy of Pilocarpine Ophthalmic Spray for Temporary Improvement of Near Vision in Presbyopic Adults (VISION-2)

Eyenovia

Status and phase: Completed; Phase 3

Conditions: Presbyopia

Treatments: Combination Product: Placebo administered with the Optejet dispenser; Combination Product: Pilocarpine Ophthalmic administered with the Optejet dispenser

Study type: Interventional

Funder types: Industry

Identifiers

NCT05114486

EYN-PRS-PI-32

Details and patient eligibility

About

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.

Enrollment: 145 patients

Sex: All

Ages: 40 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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145 participants in 2 patient groups, including a placebo group

Pilocarpine 2% Ophthalmic Spray

Experimental group

Description:

2% pilocarpine ophthalmic spray administered with the Optejet dispenser

Treatment:

Combination Product: Pilocarpine Ophthalmic administered with the Optejet dispenser

Placebo Spray

Placebo Comparator group

Description:

Placebo ophthalmic spray administered with the Optejet dispenser

Treatment:

Combination Product: Placebo administered with the Optejet dispenser