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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04657172
Recruitment Status : Enrolling by invitation
First Posted : December 8, 2020
Last Update Posted : January 6, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Presbyopia Drug: Pilocarpine Ophthalmic Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 15, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


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 Name: 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 Name: MicroLine

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




Primary Outcome Measures :
  1. Proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular distance corrected near visual acuity (DCNVA) [ Time Frame: 120 minutes post-dosing ]
    The proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular DCNVA as compared to baseline.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04657172


Locations
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United States, California
VISION-1 Study Site #21
Azusa, California, United States, 91702
VISION-1 Study Site #52
Newport Beach, California, United States, 92663
United States, Colorado
VISION-1 Study Site #54
Fort Collins, Colorado, United States, 80528
United States, Florida
VISION-1 Study Site #53
Orlando, Florida, United States, 32803
United States, New York
VISION-1 Study Site #50
New York, New York, United States, 10036
United States, North Carolina
VISION-1 Study Site #17
High Point, North Carolina, United States, 27262
VISION-1 Study Site #22
Raleigh, North Carolina, United States, 27603
United States, Pennsylvania
VISION-1 Study Site #51
Cranberry Township, Pennsylvania, United States, 16066
United States, Texas
VISION-1 Study Site #03
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Eyenovia Inc.
Investigators
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Study Chair: Tsontcho (Sean) Ianchulev, MD, MPH Eyenovia Inc.
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Responsible Party: Eyenovia Inc.
ClinicalTrials.gov Identifier: NCT04657172    
Other Study ID Numbers: EYN-PRS-PI-31
First Posted: December 8, 2020    Key Record Dates
Last Update Posted: January 6, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases
Pilocarpine
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action