Safety & Efficacy of Pilocarpine Ophthalmic Spray for Temporary Improvement of Near Vision in Presbyopic Adults

Presbyopia Clinical Trial

— VISION-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05114486
• Other study ID #: EYN-PRS-PI-32
• Status: Completed
• Phase: Phase 3
• Start date: November 3, 2021
• Est. completion date: September 20, 2022

Study information

• Verified date: September 2023
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: September 20, 2022
• Est. primary completion date: September 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 55 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

• 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

Related Conditions & MeSH terms

• Presbyopia

Intervention

Combination Product:
• Pilocarpine Ophthalmic administered with the Optejet dispenser
Pilocarpine 2% ophthalmic spray administered with the Optejet dispenser
• Placebo administered with the Optejet dispenser
Vehicle ophthalmic solution administered with the Optejet dispenser

Locations

Country	Name	City	State
United States	VISON-2 Study Site #60	Austin	Texas
United States	VISION-2 Study Site #19	Columbus	Ohio
United States	VISION-2 Study Site #61	Draper	Utah
United States	VISION-2 Study Site #59	Fairfield	Connecticut
United States	VISION-2 Study Site #56	Louisville	Kentucky
United States	VISION-2 Study Site #55	Memphis	Tennessee
United States	VISION-2 Study Site #58	Philadelphia	Pennsylvania
United States	VISION-2 Study Site #57	San Diego	California
United States	VISION-2 Study Site #62	Sioux Falls	South Dakota

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) 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