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

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.

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Key information

Conditions

Presbyopia Eye Diseases Refractive Errors

Age range

40 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

VISION-2 Study Site #57, San Diego, California, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pilocarpine Ophthalmic administered with the Optejet dispenser

Combination Product

Pilocarpine 2% ophthalmic spray administered with the Optejet dispenser

Other names: MicroLine

Placebo administered with the Optejet dispenser

Combination Product

Vehicle ophthalmic solution administered with the Optejet dispenser

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Eyenovia Inc.

Industry

Registry information

Official study 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

Acronym: VISION-2

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Nov 10, 2021
Registry last updated: Sep 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed