Safety & Efficacy of Pilocarpine Eye Solutions for Temporary Improvement of Near Vision in Presbyopic Adults

NCT04657172 | Completed Phase 3 FDA Drug

• 1 other identifier: EYN-PRS-PI-31
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 9

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.

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Pilocarpine 1% Solution

EXPERIMENTAL

1% pilocarpine ophthalmic solution administered with the Optejet dispenser

Drug: Pilocarpine Ophthalmic

Pilocarpine 2% Solution

EXPERIMENTAL

2% pilocarpine ophthalmic solution administered with the Optejet dispenser

Drug: Pilocarpine Ophthalmic

Placebo Solution

PLACEBO COMPARATOR

Placebo ophthalmic solution administered with the Optejet dispenser

Drug: Placebo

Interventions

Pilocarpine Ophthalmic DRUG

Pilocarpine 1% or 2% ophthalmic solution administered with the Optejet microdose dispenser

Also known as: MicroLine

Pilocarpine 1% Solution; Pilocarpine 2% Solution

Placebo DRUG

Vehicle ophthalmic solution administered with the Optejet microdose dispenser

Placebo Solution

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eyenovia Inc.: lead

Study Sites (9)

VISION-1 Study Site #21

Azusa, California, 91702, United States

Location

VISION-1 Study Site #52

Newport Beach, California, 92663, United States

Location

VISION-1 Study Site #54

Fort Collins, Colorado, 80528, United States

Location

VISION-1 Study Site #53

Orlando, Florida, 32803, United States

Location

VISION-1 Study Site #50

New York, New York, 10036, United States

Location

VISION-1 Study Site #17

High Point, North Carolina, 27262, United States

Location

VISION-1 Study Site #22

Raleigh, North Carolina, 27603, United States

Location

VISION-1 Study Site #51

Cranberry Township, Pennsylvania, 16066, United States

Location

VISION-1 Study Site #03

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Tsontcho (Sean) Ianchulev, MD, MPH

  Eyenovia Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 8, 2020
• Study Start: December 15, 2020
• Primary Completion: March 26, 2021
• Study Completion: March 26, 2021
• Last Updated: August 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)