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

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: NCT05114486
Recruitment Status : Completed
First Posted : November 10, 2021
Last Update Posted : September 11, 2023
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 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
Presbyopia Combination Product: Pilocarpine Ophthalmic administered with the Optejet dispenser Combination Product: Placebo administered with the Optejet dispenser Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 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 : November 3, 2021
Actual Primary Completion Date : September 20, 2022
Actual Study Completion Date : September 20, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pilocarpine 2% Ophthalmic Spray
2% pilocarpine ophthalmic spray administered with the Optejet dispenser
Combination Product: Pilocarpine Ophthalmic administered with the Optejet dispenser
Pilocarpine 2% ophthalmic spray administered with the Optejet dispenser
Other Name: MicroLine

Placebo Comparator: Placebo Spray
Placebo ophthalmic spray administered with the Optejet dispenser
Combination Product: Placebo administered with the Optejet dispenser
Vehicle ophthalmic solution administered with the Optejet dispenser




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) [ Time Frame: 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.



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 55 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
  • 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

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): NCT05114486


Locations
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United States, California
VISION-2 Study Site #57
San Diego, California, United States, 92131
United States, Connecticut
VISION-2 Study Site #59
Fairfield, Connecticut, United States, 06890
United States, Kentucky
VISION-2 Study Site #56
Louisville, Kentucky, United States, 40206
United States, Ohio
VISION-2 Study Site #19
Columbus, Ohio, United States, 43210
United States, Pennsylvania
VISION-2 Study Site #58
Philadelphia, Pennsylvania, United States, 19141
United States, South Dakota
VISION-2 Study Site #62
Sioux Falls, South Dakota, United States, 57018
United States, Tennessee
VISION-2 Study Site #55
Memphis, Tennessee, United States, 38119
United States, Texas
VISON-2 Study Site #60
Austin, Texas, United States, 78731
United States, Utah
VISION-2 Study Site #61
Draper, Utah, United States, 84020
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: NCT05114486    
Other Study ID Numbers: EYN-PRS-PI-32
First Posted: November 10, 2021    Key Record Dates
Last Update Posted: September 11, 2023
Last Verified: September 2023
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