Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Dry Eye Disease

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 Signs and Symptoms of Dry Eye Disease.

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 Signs and Symptoms of Dry Eye Disease

Conditions
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Dry Eye Disease, Kerato Conjunctivitis Sicca

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: Male or female, 18 years of age or older at the Screening Visit Willing and able to provide written informed consent on the IRB/IEC-approved informed consent form Diagnosis of dry eye 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 such as lotions, creams, makeup, soaps, etc. History of, or active iritis or uveitis in either eye Pre-existing retinal disease in either eye that may predispose subjects to retinal detachment

Ages Eligible for Study
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Minimum Age: 18 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-301;|
| 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-301;|
| 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-301;|
| 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 |
| --- | --- | --- |
| Mean change from baseline in the VAS score at Day 28 visit. | Mean change from baseline in the VAS score at Day 28 visit. Visual Analogue Scale from 0 (no discomfort) to 100 (maximal discomfort) | Baseline and Day 28 | 
| Mean change from baseline in Fluorescein Staining at the Day 28 visit. | Mean change from baseline in Fluorescein Staining at the Day 28 visit. | Baseline and Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in the VAS score at the Day 4, 8, and 14 visits | Mean change from baseline in the VAS score at the Day 4, 8, and 14 visits Visual Analogue Scale from 0 (no discomfort) to 100 (maximal discomfort) | Baseline and Days 4, 8, and 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry eye syndromes, Eye diseases, Corneal diseases, Keratoconjunctivitis, Pilocarpine