Safety & Efficacy of Pilocarpine Eye Solutions for Temporary Improvement of Near Vision in Presbyopic Adults
- Registration Number
- NCT04657172
- Lead Sponsor
- Eyenovia Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Pilocarpine 1% Solution Pilocarpine Ophthalmic 1% pilocarpine ophthalmic solution administered with the Optejet dispenser Placebo Solution Placebo Placebo ophthalmic solution administered with the Optejet dispenser Pilocarpine 2% Solution Pilocarpine Ophthalmic 2% pilocarpine ophthalmic solution administered with the Optejet dispenser
- Primary Outcome Measures
Name Time Method Proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular distance corrected near visual acuity (DCNVA) 120 minutes post-dosing The proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular DCNVA as compared to baseline.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
VISION-1 Study Site #54
🇺🇸Fort Collins, Colorado, United States
VISION-1 Study Site #21
🇺🇸Azusa, California, United States
VISION-1 Study Site #53
🇺🇸Orlando, Florida, United States
VISION-1 Study Site #52
🇺🇸Newport Beach, California, United States
VISION-1 Study Site #50
🇺🇸New York, New York, United States
VISION-1 Study Site #17
🇺🇸High Point, North Carolina, United States
VISION-1 Study Site #51
🇺🇸Cranberry Township, Pennsylvania, United States
VISION-1 Study Site #22
🇺🇸Raleigh, North Carolina, United States
VISION-1 Study Site #03
🇺🇸San Antonio, Texas, United States