Clinical trial NCT04657172: Safety & Efficacy of Pilocarpine Eye Solutions for Temporary Improvement of Near Vision in Presbyopic Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Presbyopia
Lead sponsor: Eyenovia Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-08
Enrollment: 84
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular distance corrected near visual acuity (DCNVA)
timeFrame: 120 minutes post-dosing
Secondary outcomes:
Other outcomes:
Locations:
city: Azusa
country: United States
facility: VISION-1 Study Site #21
state: California
city: Newport Beach
country: United States
facility: VISION-1 Study Site #52
state: California
city: Fort Collins
country: United States
facility: VISION-1 Study Site #54
state: Colorado
city: Orlando
country: United States
facility: VISION-1 Study Site #53
state: Florida
city: New York
country: United States
facility: VISION-1 Study Site #50
state: New York
city: High Point
country: United States
facility: VISION-1 Study Site #17
state: North Carolina
city: Raleigh
country: United States
facility: VISION-1 Study Site #22
state: North Carolina
city: Cranberry Township
country: United States
facility: VISION-1 Study Site #51
state: Pennsylvania
city: San Antonio
country: United States
facility: VISION-1 Study Site #03
state: Texas
Study officials:
affiliation: Eyenovia Inc.
name: Tsontcho (Sean) Ianchulev, MD, MPH
role: STUDY_CHAIR
References: