VISION-2: Safety & Efficacy of Pilocarpine Ophthalmic Spray for Temporary Improvement of Near Vision in Presbyopic Adults
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Pilocarpine 2% Ophthalmic Spray 2% pilocarpine ophthalmic spray administered with the Optejet dispenser |
Drug: Pilocarpine Ophthalmic
Pilocarpine 2% ophthalmic spray administered with the Optejet microdose dispenser
Other Names:
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Placebo Comparator: Placebo Spray Placebo ophthalmic spray administered with the Optejet dispenser |
Drug: Placebo
Vehicle ophthalmic solution administered with the Optejet microdose dispenser
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Outcome Measures
Primary Outcome Measures
- 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) [120 minutes post-dosing]
The proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular DCNVA with ≤ 5 letter loss DVA as compared to baseline.
Eligibility Criteria
Criteria
Primary Inclusion Criteria:
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Poor near vision impacting daily living that requires near correction
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Best-corrected distance visual acuity (BCDVA) of 0.0 logMar or better
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Manifest refraction spherical equivalent ≥ -2.00 Diopters (D) and ≤ +2.00 D
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Monocular DCNVA between 0.4 and 0.7 logMAR, inclusive
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In need of near addition power < +2.00 D to achieve BCNVA of 0.0 logMAR
Primary Exclusion Criteria:
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Diagnosis of glaucoma or ocular hypertension
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Narrow iridocorneal angles
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History of intraocular surgery, refractive surgery, laser treatment, or iris surgery
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Clinically significant abnormality of cornea, lens, retina, ciliary body, or iris
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Presence/history of a severe/serious ocular condition or any other unstable medical condition
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Presence or history of manifest strabismus, amblyopia, or nystagmus
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Current active eye disease for which topical or systemic ophthalmic medication is necessary, except for dry eye syndrome managed using artificial tears
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Clinically significant external ocular inflammation within 30 days of Screening Visit
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Current use or history of rigid gas permeable (RGP) contact lens use within 30 days of Screening Visit
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Known pilocarpine allergy or contraindication to use of pilocarpine
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Presence or history of congenital heart anomaly, valve disease, or other cardiac disease
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Disabling arthritis or limited motor coordination that would limit the subject's ability to self-administer study solution using the Optejet
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | VISION-2 Study Site #57 | San Diego | California | United States | 92131 |
2 | VISION-2 Study Site #59 | Fairfield | Connecticut | United States | 06890 |
3 | VISION-2 Study Site #56 | Louisville | Kentucky | United States | 40206 |
4 | VISION-2 Study Site #19 | Columbus | Ohio | United States | 43210 |
5 | VISION-2 Study Site #58 | Philadelphia | Pennsylvania | United States | 19141 |
6 | VISION-2 Study Site #62 | Sioux Falls | South Dakota | United States | 57018 |
7 | VISION-2 Study Site #55 | Memphis | Tennessee | United States | 38119 |
8 | VISON-2 Study Site #60 | Austin | Texas | United States | 78731 |
9 | VISION-2 Study Site #61 | Draper | Utah | United States | 84020 |
Sponsors and Collaborators
- Eyenovia Inc.
Investigators
- Study Chair: Tsontcho (Sean) Ianchulev, MD, MPH, Eyenovia Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EYN-PRS-PI-32