Safety and Efficacy Study of BRIMOCHOL™, BRIMOCHOL™ F, and Carbachol in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia

Study Overview
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Brief Summary
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Safety and Efficacy Study of BRIMOCHOL™ vs. BRIMOCHOL™ F vs. Carbachol Monotherapy Topical Ophthalmic Solutions in Subjects with Emmetropic Phakic and Pseudophakic Presbyopia

Detailed Description
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A 3-Dose, Multicenter, Randomized, Double-Masked, Crossover Phase 2 Safety and Efficacy Study of BRIMOCHOL™ Topical Ophthalmic Solution vs. BRIMOCHOL™ F Topical Ophthalmic Solution vs. Monotherapy with Carbachol Topical Ophthalmic Solution in Subjects with Emmetropic Phakic and Pseudophakic Presbyopia

Official Title
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A 3-Dose, Multicenter, Randomized, Double-Masked, Crossover Phase 2 Safety and Efficacy Study of BRIMOCHOL™ Topical Ophthalmic Solution vs. BRIMOCHOL™ F Topical Ophthalmic Solution vs. Monotherapy With Carbachol Topical Ophthalmic Solution in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia

Conditions
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Presbyopia

Intervention / Treatment
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* Drug: BRIMOCHOL™
* Drug: BRIMOCHOL™ F
* Drug: Carbachol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female in good general health Must have presbyopia Exclusion Criteria: History of allergic reaction to the study drug or any of its components Any disease or medical condition that, in the opinion of the Investigator, would prevent the subject from participating in the study or might confound study results

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BRIMOCHOL™<br>A single drop in each eye at a visit. | Drug: BRIMOCHOL™<br>* A single drop in each eye at a visit.<br>* Other names: carbachol/brimonidine tartrate;|
| Experimental: BRIMOCHOL™ F<br>A single drop in each eye at a visit. | Drug: BRIMOCHOL™ F<br>* A single drop in each eye at a visit.<br>* Other names: carbachol/brimonidine tartrate;|
| Active Comparator: Carbachol<br>A single drop in each eye at a visit. | Drug: Carbachol<br>* A single drop in each eye at a visit.<br>* Other names: carbachol monotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in near VA | Percentage of subjects with 3-line gains in near VA at various time points | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in distance VA | Percentage of subjects with 1-line loss in distance VA at various time points | From baseline through hour 9 at each study visit |