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

Study Overview
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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.

Official Title
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Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream BID for the Treatment of Presbyopia

Conditions
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Presbyopia

Intervention / Treatment
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* Drug: Pilocarpine Ophthalmic Topical Cream, Dose 1
* Drug: Pilocarpine Ophthalmic Topical Cream, Dose 2
* Drug: Pilocarpine Ophthalmic Topical Cream, Dose 3
* Drug: Placebo Ophthalmic Topical Cream


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pilocarpine Ophthalmic Topical Cream, Dose 1<br>Pilocarpine Ophthalmic Topical Cream, Dose 1 | Drug: Pilocarpine Ophthalmic Topical Cream, Dose 1<br>* Pilocarpine Ophthalmic Topical Cream, Dose 1<br>* Other names: GLK-302;|
| Experimental: Pilocarpine Ophthalmic Topical Cream, Dose 2<br>Pilocarpine Ophthalmic Topical Cream, Dose 2 | Drug: Pilocarpine Ophthalmic Topical Cream, Dose 2<br>* Pilocarpine Ophthalmic Topical Cream, Dose 2<br>* Other names: GLK-302;|
| Experimental: Pilocarpine Ophthalmic Topical Cream, Dose 3<br>Pilocarpine Ophthalmic Topical Cream, Dose 3 | Drug: Pilocarpine Ophthalmic Topical Cream, Dose 3<br>* Pilocarpine Ophthalmic Topical Cream, Dose 3<br>* Other names: GLK-302;|
| Placebo Comparator: Placebo Ophthalmic Topical Cream<br>Placebo Ophthalmic Topical Cream | Drug: Placebo Ophthalmic Topical Cream<br>* Placebo Ophthalmic Topical Cream<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binocular Distance Corrected Near Visual Acuity (DCNVA) | Proportion of treatment responders [subjects gaining 3 lines or more in binocular distance corrected near visual acuity (DCNVA) and not losing more than 5 letters of binocular best corrected distance visual acuity (BCDVA)] 1 hour post-dose at the Day 28 visit. | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of treatment responders (as defined for the primary endpoint) at 0.5, 2, 4, and 6 hours post-dose at the day 28 visit. | Proportion of treatment responders (as defined for the primary endpoint) at 0.5, 2, 4, and 6 hours post-dose at the day 28 visit. | Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pilocarpine, Refractive errors, Loss of near vision