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

Primary Purpose

Presbyopia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Pilocarpine Ophthalmic administered with the Optejet dispenser
Placebo administered with the Optejet dispenser
Sponsored by
Eyenovia Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia

Eligibility Criteria

40 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • VISION-2 Study Site #57
  • VISION-2 Study Site #59
  • VISION-2 Study Site #56
  • VISION-2 Study Site #19
  • VISION-2 Study Site #58
  • VISION-2 Study Site #62
  • VISION-2 Study Site #55
  • VISON-2 Study Site #60
  • VISION-2 Study Site #61

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pilocarpine 2% Ophthalmic Spray

Placebo Spray

Arm Description

2% pilocarpine ophthalmic spray administered with the Optejet dispenser

Placebo ophthalmic spray administered with the Optejet dispenser

Outcomes

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)
The proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular DCNVA with ≤ 5 letter loss DVA as compared to baseline.

Secondary Outcome Measures

Full Information

First Posted
November 5, 2021
Last Updated
September 5, 2023
Sponsor
Eyenovia Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05114486
Brief Title
Safety & Efficacy of Pilocarpine Ophthalmic Spray for Temporary Improvement of Near Vision in Presbyopic Adults
Acronym
VISION-2
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 3, 2021 (Actual)
Primary Completion Date
September 20, 2022 (Actual)
Study Completion Date
September 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eyenovia Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pilocarpine 2% Ophthalmic Spray
Arm Type
Experimental
Arm Description
2% pilocarpine ophthalmic spray administered with the Optejet dispenser
Arm Title
Placebo Spray
Arm Type
Placebo Comparator
Arm Description
Placebo ophthalmic spray administered with the Optejet dispenser
Intervention Type
Combination Product
Intervention Name(s)
Pilocarpine Ophthalmic administered with the Optejet dispenser
Other Intervention Name(s)
MicroLine
Intervention Description
Pilocarpine 2% ophthalmic spray administered with the Optejet dispenser
Intervention Type
Combination Product
Intervention Name(s)
Placebo administered with the Optejet dispenser
Intervention Description
Vehicle ophthalmic solution administered with the Optejet dispenser
Primary Outcome Measure Information:
Title
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)
Description
The proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular DCNVA with ≤ 5 letter loss DVA as compared to baseline.
Time Frame
120 minutes post-dosing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsontcho (Sean) Ianchulev, MD, MPH
Organizational Affiliation
Eyenovia Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
VISION-2 Study Site #57
City
San Diego
State/Province
California
ZIP/Postal Code
92131
Country
United States
Facility Name
VISION-2 Study Site #59
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06890
Country
United States
Facility Name
VISION-2 Study Site #56
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
VISION-2 Study Site #19
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
VISION-2 Study Site #58
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
VISION-2 Study Site #62
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57018
Country
United States
Facility Name
VISION-2 Study Site #55
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
VISON-2 Study Site #60
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
VISION-2 Study Site #61
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety & Efficacy of Pilocarpine Ophthalmic Spray for Temporary Improvement of Near Vision in Presbyopic Adults

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