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

• ClinicalTrials.gov Identifier: NCT04657172
• Recruitment Status: Enrolling by invitation
• First Posted: December 8, 2020
• Last Update Posted: January 6, 2021
• 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 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.

Condition or disease	Intervention/treatment	Phase
Presbyopia	Drug: Pilocarpine Ophthalmic; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 84 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 1% and 2% Pilocarpine Ophthalmic Solutions Administered With the Optejet® Microdose Dispenser for Temporary Improvement of Near Vision in Adults With Presbyopia
• Actual Study Start Date: December 15, 2020
• Estimated Primary Completion Date: March 31, 2021
• Estimated Study Completion Date: March 31, 2021

Arms and Interventions

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 Name: 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 Name: MicroLine
Placebo Comparator: Placebo Solution; Placebo ophthalmic solution administered with the Optejet dispenser	Drug: Placebo; Vehicle ophthalmic solution administered with the Optejet microdose dispenser

Outcome Measures

Primary Outcome Measures :

1. Proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular distance corrected near visual acuity (DCNVA) [ Time Frame: 120 minutes post-dosing ]
   The proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular DCNVA as compared to baseline.

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 60 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

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-1 Study Site #21

Azusa, California, United States, 91702

VISION-1 Study Site #52

Newport Beach, California, United States, 92663

United States, Colorado

VISION-1 Study Site #54

Fort Collins, Colorado, United States, 80528

United States, Florida

VISION-1 Study Site #53

Orlando, Florida, United States, 32803

United States, New York

VISION-1 Study Site #50

New York, New York, United States, 10036

United States, North Carolina

VISION-1 Study Site #17

High Point, North Carolina, United States, 27262

VISION-1 Study Site #22

Raleigh, North Carolina, United States, 27603

United States, Pennsylvania

VISION-1 Study Site #51

Cranberry Township, Pennsylvania, United States, 16066

United States, Texas

VISION-1 Study Site #03

San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Eyenovia Inc.

Investigators

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

More Information

• Responsible Party: Eyenovia Inc.
• ClinicalTrials.gov Identifier: NCT04657172
• Other Study ID Numbers: EYN-PRS-PI-31
• First Posted: December 8, 2020
• Last Update Posted: January 6, 2021
• Last Verified: January 2021

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