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

• ClinicalTrials.gov Identifier: NCT05114486
• Recruitment Status: Completed
• First Posted: November 10, 2021
• Last Update Posted: September 11, 2023
• Sponsor: Eyenovia Inc.
• Information provided by (Responsible Party): Eyenovia Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Presbyopia	Combination Product: Pilocarpine Ophthalmic administered with the Optejet dispenser; Combination Product: Placebo administered with the Optejet dispenser	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 145 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: November 3, 2021
• Actual Primary Completion Date: September 20, 2022
• Actual Study Completion Date: September 20, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Pilocarpine 2% Ophthalmic Spray; 2% pilocarpine ophthalmic spray administered with the Optejet dispenser	Combination Product: Pilocarpine Ophthalmic administered with the Optejet dispenser; Pilocarpine 2% ophthalmic spray administered with the Optejet dispenser; Other Name: MicroLine
Placebo Comparator: Placebo Spray; Placebo ophthalmic spray administered with the Optejet dispenser	Combination Product: Placebo administered with the Optejet dispenser; Vehicle ophthalmic solution administered with the Optejet dispenser

Outcome Measures

Primary Outcome Measures :

1. 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) [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, California

VISION-2 Study Site #57

San Diego, California, United States, 92131

United States, Connecticut

VISION-2 Study Site #59

Fairfield, Connecticut, United States, 06890

United States, Kentucky

VISION-2 Study Site #56

Louisville, Kentucky, United States, 40206

United States, Ohio

VISION-2 Study Site #19

Columbus, Ohio, United States, 43210

United States, Pennsylvania

VISION-2 Study Site #58

Philadelphia, Pennsylvania, United States, 19141

United States, South Dakota

VISION-2 Study Site #62

Sioux Falls, South Dakota, United States, 57018

United States, Tennessee

VISION-2 Study Site #55

Memphis, Tennessee, United States, 38119

United States, Texas

VISON-2 Study Site #60

Austin, Texas, United States, 78731

United States, Utah

VISION-2 Study Site #61

Draper, Utah, United States, 84020

Sponsors and Collaborators

Eyenovia Inc.

Investigators

• Study Chair: Tsontcho (Sean) Ianchulev, MD, MPH; Eyenovia Inc.

More Information

• Responsible Party: Eyenovia Inc.
• ClinicalTrials.gov Identifier: NCT05114486
• Other Study ID Numbers: EYN-PRS-PI-32
• First Posted: November 10, 2021
• Last Update Posted: September 11, 2023
• Last Verified: September 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Presbyopia; Refractive Errors; Eye Diseases; Pilocarpine; Miotics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Muscarinic Agonists; Cholinergic Agonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action