Safety & Efficacy of Pilocarpine Eye Solutions for Temporary Improvement of Near Vision in Presbyopic Adults (VISION-1)

A Phase 3 Study of the Safety and Efficacy of 1% and 2% Pilocarpine Ophthalmic Solutions 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 3 treatment visits. At each treatment visit, 1 of the 3 study solutions 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: Drug: Pilocarpine Ophthalmic; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Azusa, California, United States, 91702
      • VISION-1 Study Site #21
    • Newport Beach, California, United States, 92663
      • VISION-1 Study Site #52
  • Colorado
    • Fort Collins, Colorado, United States, 80528
      • VISION-1 Study Site #54
  • Florida
    • Orlando, Florida, United States, 32803
      • VISION-1 Study Site #53
  • New York
    • New York, New York, United States, 10036
      • VISION-1 Study Site #50
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • VISION-1 Study Site #17
    • Raleigh, North Carolina, United States, 27603
      • VISION-1 Study Site #22
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • VISION-1 Study Site #51
  • Texas
    • San Antonio, Texas, United States, 78229
      • VISION-1 Study Site #03

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pilocarpine 1% Solution; 1% pilocarpine ophthalmic solution administered with the Optejet dispenser	Drug: Pilocarpine Ophthalmic; Pilocarpine 1% or 2% ophthalmic solution administered with the Optejet microdose dispenser; Other Names: MicroLine
Experimental: Pilocarpine 2% Solution; 2% pilocarpine ophthalmic solution administered with the Optejet dispenser	Drug: Pilocarpine Ophthalmic; Pilocarpine 1% or 2% ophthalmic solution administered with the Optejet microdose dispenser; Other Names: MicroLine
Placebo Comparator: Placebo Solution; Placebo ophthalmic solution administered with the Optejet dispenser	Drug: Placebo; Vehicle ophthalmic solution administered with the Optejet microdose 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)	The proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular DCNVA 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): December 15, 2020
• Primary Completion (Actual): March 26, 2021
• Study Completion (Actual): March 26, 2021

Study Registration Dates

• First Submitted: December 1, 2020
• First Submitted That Met QC Criteria: December 1, 2020
• First Posted (Actual): December 8, 2020

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 5, 2021
• Last Verified: August 1, 2021

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-31

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