Safety & Efficacy of Pilocarpine Ophthalmic Spray 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

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-03

Study Completion Date

2022-09-20

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 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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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 2% Ophthalmic Spray

2% pilocarpine ophthalmic spray administered with the Optejet dispenser

Group Type EXPERIMENTAL

Pilocarpine Ophthalmic administered with the Optejet dispenser

Intervention Type COMBINATION_PRODUCT

Pilocarpine 2% ophthalmic spray administered with the Optejet dispenser

Placebo Spray

Placebo ophthalmic spray administered with the Optejet dispenser

Group Type PLACEBO_COMPARATOR

Placebo administered with the Optejet dispenser

Intervention Type COMBINATION_PRODUCT

Vehicle ophthalmic solution administered with the Optejet dispenser

Interventions

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Pilocarpine Ophthalmic administered with the Optejet dispenser

Pilocarpine 2% ophthalmic spray administered with the Optejet dispenser

Intervention Type COMBINATION_PRODUCT

Placebo administered with the Optejet dispenser

Vehicle ophthalmic solution administered with the Optejet dispenser

Intervention Type COMBINATION_PRODUCT

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
* In need of near addition power \< +2.00 D to achieve BCNVA of 0.0 logMAR

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

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes