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VISION-1: Safety & Efficacy of Pilocarpine Eye Solutions for Temporary Improvement of Near Vision in Presbyopic Adults

Sponsor
Eyenovia Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04657172
Collaborator
(none)
84
Enrollment
9
Locations
3
Arms
3.3
Actual Duration (Months)
9.3
Patients Per Site
2.8
Patients Per Site Per Month

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 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Pilocarpine Ophthalmic
  • Drug: Placebo
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
84 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 1% and 2% Pilocarpine Ophthalmic Solutions Administered With the Optejet® Microdose Dispenser for Temporary Improvement of Near Vision in Adults With Presbyopia
Actual Study Start Date :
Dec 15, 2020
Actual Primary Completion Date :
Mar 26, 2021
Actual Study Completion Date :
Mar 26, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pilocarpine 1% Solution

1% pilocarpine ophthalmic solution administered with the Optejet dispenser

Drug: Pilocarpine Ophthalmic
Pilocarpine 1% or 2% ophthalmic solution administered with the Optejet microdose dispenser
Other Names:
  • MicroLine

    		•
    Experimental: Pilocarpine 2% Solution

    2% pilocarpine ophthalmic solution administered with the Optejet dispenser

    Drug: Pilocarpine Ophthalmic
    Pilocarpine 1% or 2% ophthalmic solution administered with the Optejet microdose dispenser
    Other Names:
  • MicroLine

    		•
    Placebo Comparator: Placebo Solution

    Placebo ophthalmic solution 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) [120 minutes post-dosing]

      The proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular DCNVA as compared to baseline.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 60 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

    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-1 Study Site #21 Azusa California United States 91702
    2 VISION-1 Study Site #52 Newport Beach California United States 92663
    3 VISION-1 Study Site #54 Fort Collins Colorado United States 80528
    4 VISION-1 Study Site #53 Orlando Florida United States 32803
    5 VISION-1 Study Site #50 New York New York United States 10036
    6 VISION-1 Study Site #17 High Point North Carolina United States 27262
    7 VISION-1 Study Site #22 Raleigh North Carolina United States 27603
    8 VISION-1 Study Site #51 Cranberry Township Pennsylvania United States 16066
    9 VISION-1 Study Site #03 San Antonio Texas United States 78229

    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:
    NCT04657172
    Other Study ID Numbers:
    • EYN-PRS-PI-31
    First Posted:
    Dec 8, 2020
    Last Update Posted:
    Aug 9, 2021
    Last Verified:
    Aug 1, 2021
    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:
    Presbyopia
    Pilocarpine

    Study Results

    No Results Posted as of Aug 9, 2021