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

Phase 3

Completed

• Conditions: Presbyopia
• Interventions: Combination Product: Pilocarpine Ophthalmic administered with the Optejet dispenser; Combination Product: Placebo administered with the Optejet dispenser

• Registration Number: NCT05114486
• Lead Sponsor: Eyenovia Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-03
• Study First Submitted: 2021-11-05
• Study First Submitted QC: 2021-11-05
• Study First Posted: 2021-11-10
• Primary Completion: 2022-09-20
• Study Completion: 2022-09-20
• Disposition First Submitted: 2023-08-29
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-05
• Disposition First Posted: 2023-09-11
• Last Update Posted: 2023-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pilocarpine 2% Ophthalmic Spray	Pilocarpine Ophthalmic administered with the Optejet dispenser	2% pilocarpine ophthalmic spray administered with the Optejet dispenser
Placebo Spray	Placebo administered with the Optejet dispenser	Placebo ophthalmic spray administered with the Optejet dispenser

Primary Outcome Measures

Name	Time	Method
Proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular distance corrected near visual acuity (DCNVA) with ≤ 5 letter loss in mesopic, high contrast, binocular distance visual acuity (DVA)	120 minutes post-dosing	The proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular DCNVA with ≤ 5 letter loss DVA as compared to baseline.

Trial Locations

Locations (9)

VISION-2 Study Site #61; 🇺🇸 Draper, Utah, United States

VISION-2 Study Site #56; 🇺🇸 Louisville, Kentucky, United States

VISION-2 Study Site #19; 🇺🇸 Columbus, Ohio, United States

VISION-2 Study Site #57; 🇺🇸 San Diego, California, United States

VISION-2 Study Site #55; 🇺🇸 Memphis, Tennessee, United States

VISION-2 Study Site #59; 🇺🇸 Fairfield, Connecticut, United States

VISON-2 Study Site #60; 🇺🇸 Austin, Texas, United States

VISION-2 Study Site #58; 🇺🇸 Philadelphia, Pennsylvania, United States

VISION-2 Study Site #62; 🇺🇸 Sioux Falls, South Dakota, United States