NCT05114486

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2021

Shorter than P25 for phase_3

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 3, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 10, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2022

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

11 months

First QC Date

November 5, 2021

Last Update Submit

September 5, 2023

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (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)

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

    120 minutes post-dosing

Study Arms (2)

Pilocarpine 2% Ophthalmic Spray

EXPERIMENTAL

2% pilocarpine ophthalmic spray administered with the Optejet dispenser

Combination Product: Pilocarpine Ophthalmic administered with the Optejet dispenser

Placebo Spray

PLACEBO COMPARATOR

Placebo ophthalmic spray administered with the Optejet dispenser

Combination Product: Placebo administered with the Optejet dispenser

Interventions

Pilocarpine Ophthalmic administered with the Optejet dispenserCOMBINATION_PRODUCT

Pilocarpine 2% ophthalmic spray administered with the Optejet dispenser

Also known as: MicroLine
Pilocarpine 2% Ophthalmic Spray
Placebo administered with the Optejet dispenserCOMBINATION_PRODUCT

Vehicle ophthalmic solution administered with the Optejet dispenser

Placebo Spray

Eligibility Criteria

Age40 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

VISION-2 Study Site #57

San Diego, California, 92131, United States

Location

VISION-2 Study Site #59

Fairfield, Connecticut, 06890, United States

Location

VISION-2 Study Site #56

Louisville, Kentucky, 40206, United States

Location

VISION-2 Study Site #19

Columbus, Ohio, 43210, United States

Location

VISION-2 Study Site #58

Philadelphia, Pennsylvania, 19141, United States

Location

VISION-2 Study Site #62

Sioux Falls, South Dakota, 57018, United States

Location

VISION-2 Study Site #55

Memphis, Tennessee, 38119, United States

Location

VISON-2 Study Site #60

Austin, Texas, 78731, United States

Location

VISION-2 Study Site #61

Draper, Utah, 84020, United States

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Tsontcho (Sean) Ianchulev, MD, MPH

    Eyenovia Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2021

First Posted

November 10, 2021

Study Start

November 3, 2021

Primary Completion

September 20, 2022

Study Completion

September 20, 2022

Last Updated

September 11, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(9)