Safety & Efficacy of Pilocarpine Eye Solutions for Temporary Improvement of Near Vision in Presbyopic Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-15

Study Completion Date

2021-03-26

Brief Summary

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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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Detailed Description

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Conditions

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Presbyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Pilocarpine 1% Solution

1% pilocarpine ophthalmic solution administered with the Optejet dispenser

Group Type EXPERIMENTAL

Pilocarpine Ophthalmic

Intervention Type DRUG

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

Pilocarpine 2% Solution

2% pilocarpine ophthalmic solution administered with the Optejet dispenser

Group Type EXPERIMENTAL

Pilocarpine Ophthalmic

Intervention Type DRUG

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

Placebo Solution

Placebo ophthalmic solution administered with the Optejet dispenser

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Vehicle ophthalmic solution administered with the Optejet microdose dispenser

Interventions

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Pilocarpine Ophthalmic

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

Intervention Type DRUG

Placebo

Vehicle ophthalmic solution administered with the Optejet microdose dispenser

Intervention Type DRUG

Other Intervention Names

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MicroLine

Eligibility Criteria

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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

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes