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OpenTrials
Completed

NCT Number: NCT04657172

Safety & Efficacy of Pilocarpine Eye Solutions 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 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.

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Key information

Conditions

Presbyopia Eye Diseases Refractive Errors

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

VISION-1 Study Site #21, Azusa, California, United States

Loading trial locations.

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

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

Drug

Pilocarpine 1% or 2% ophthalmic solution administered with the Optejet microdose dispenser

Other names: MicroLine

Placebo

Drug

Vehicle ophthalmic solution administered with the Optejet microdose dispenser

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Eyenovia Inc.

Industry

Registry information

Official study 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

Acronym: VISION-1

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 8, 2020
Registry last updated
Aug 9, 2021

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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