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

Presbyopia Clinical Trial

— VISION-1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04657172
• Other study ID #: EYN-PRS-PI-31
• Status: Completed
• Phase: Phase 3
• Start date: December 15, 2020
• Est. completion date: March 26, 2021

Study information

• Verified date: August 2021
• Source: Eyenovia Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: March 26, 2021
• Est. primary completion date: March 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Presbyopia

Intervention

Drug:
• Pilocarpine Ophthalmic
Pilocarpine 1% or 2% ophthalmic solution administered with the Optejet microdose dispenser
• Placebo
Vehicle ophthalmic solution administered with the Optejet microdose dispenser

Locations

Country	Name	City	State
United States	VISION-1 Study Site #21	Azusa	California
United States	VISION-1 Study Site #51	Cranberry Township	Pennsylvania
United States	VISION-1 Study Site #54	Fort Collins	Colorado
United States	VISION-1 Study Site #17	High Point	North Carolina
United States	VISION-1 Study Site #50	New York	New York
United States	VISION-1 Study Site #52	Newport Beach	California
United States	VISION-1 Study Site #53	Orlando	Florida
United States	VISION-1 Study Site #22	Raleigh	North Carolina
United States	VISION-1 Study Site #03	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eyenovia Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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