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

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

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.

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Combination product: Pilocarpine Ophthalmic administered with the Optejet dispenser; Combination product: Placebo administered with the Optejet dispenser

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92131
      • VISION-2 Study Site #57
  • Connecticut
    • Fairfield, Connecticut, United States, 06890
      • VISION-2 Study Site #59
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • VISION-2 Study Site #56
  • Ohio
    • Columbus, Ohio, United States, 43210
      • VISION-2 Study Site #19
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19141
      • VISION-2 Study Site #58
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57018
      • VISION-2 Study Site #62
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • VISION-2 Study Site #55
  • Texas
    • Austin, Texas, United States, 78731
      • VISON-2 Study Site #60
  • Utah
    • Draper, Utah, United States, 84020
      • VISION-2 Study Site #61

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	The proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular DCNVA with ≤ 5 letter loss DVA as compared to baseline.	120 minutes post-dosing

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2021
• Primary Completion (Actual): September 20, 2022
• Study Completion (Actual): September 20, 2022

Study Registration Dates

• First Submitted: November 5, 2021
• First Submitted That Met QC Criteria: November 5, 2021
• First Posted (Actual): November 10, 2021

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Cholinergic Agonists; Miotics; Muscarinic Agonists; Pilocarpine
• Other Study ID Numbers: EYN-PRS-PI-32

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No