VISION-2: Safety & Efficacy of Pilocarpine Ophthalmic Spray for Temporary Improvement of Near Vision in Presbyopic Adults

Sponsor
Eyenovia Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05114486
Collaborator
(none)
139
9
2
7.9
15.4
2

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
  • Drug: Pilocarpine Ophthalmic
  • Drug: Placebo
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
139 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 3, 2021
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
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:
  • MicroLine
  • Placebo Comparator: Placebo Spray

    Placebo ophthalmic spray administered with the Optejet dispenser

    Drug: Placebo
    Vehicle ophthalmic solution administered with the Optejet microdose dispenser

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Ages Eligible for Study:
    40 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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.
    Responsible Party:
    Eyenovia Inc.
    ClinicalTrials.gov Identifier:
    NCT05114486
    Other Study ID Numbers:
    • EYN-PRS-PI-32
    First Posted:
    Nov 10, 2021
    Last Update Posted:
    May 9, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 9, 2022