Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Presbyopia

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

PHASE2

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-03

Study Completion Date

2022-09-06

Brief Summary

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This is a Multicenter, Randomized, Double-Masked Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Presbyopia.

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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

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pilocarpine Ophthalmic Topical Cream, Dose 1

Group Type EXPERIMENTAL

Pilocarpine Ophthalmic Topical Cream, Dose 1

Intervention Type DRUG

Pilocarpine Ophthalmic Topical Cream, Dose 1

Pilocarpine Ophthalmic Topical Cream, Dose 2

Group Type EXPERIMENTAL

Pilocarpine Ophthalmic Topical Cream, Dose 2

Intervention Type DRUG

Pilocarpine Ophthalmic Topical Cream, Dose 2

Pilocarpine Ophthalmic Topical Cream, Dose 3

Group Type EXPERIMENTAL

Pilocarpine Ophthalmic Topical Cream, Dose 3

Intervention Type DRUG

Pilocarpine Ophthalmic Topical Cream, Dose 3

Placebo Ophthalmic Topical Cream

Group Type PLACEBO_COMPARATOR

Placebo Ophthalmic Topical Cream

Intervention Type DRUG

Placebo Ophthalmic Topical Cream

Interventions

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Pilocarpine Ophthalmic Topical Cream, Dose 1

Intervention Type DRUG

Pilocarpine Ophthalmic Topical Cream, Dose 2

Intervention Type DRUG

Pilocarpine Ophthalmic Topical Cream, Dose 3

Intervention Type DRUG

Placebo Ophthalmic Topical Cream

Intervention Type DRUG

Other Intervention Names

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GLK-302 GLK-302 GLK-302 Placebo

Eligibility Criteria

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Inclusion Criteria

* Presbyopic male or female 40-55 years of age
* Willing and able to provide written informed consent on the IRB/IEC approved informed consent form

Exclusion Criteria

* Sensitivity or known allergy to pilocarpine or any of the other excipients of the formulation
* History of eczema, dermatitis or skin sensitivity to over-the-counter personal care products
* History of, or active, iritis or uveitis in either eye
* Pre-existing retinal diseases in either eye that may pre-dispose the subjects to retinal detachment

Minimum Eligible Age

40 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No