Safety and Efficacy Study of BRIMOCHOL™, BRIMOCHOL™ F, and Carbachol in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia
Study Details
Study Description
Brief Summary
Safety and Efficacy Study of BRIMOCHOL™ vs. BRIMOCHOL™ F vs. Carbachol Monotherapy Topical Ophthalmic Solutions in Subjects with Emmetropic Phakic and Pseudophakic Presbyopia
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
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
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: BRIMOCHOL™ A single drop in each eye at a visit. |
Drug: BRIMOCHOL™
A single drop in each eye at a visit.
Other Names:
|
Experimental: BRIMOCHOL™ F A single drop in each eye at a visit. |
Drug: BRIMOCHOL™ F
A single drop in each eye at a visit.
Other Names:
|
Active Comparator: Carbachol A single drop in each eye at a visit. |
Drug: Carbachol
A single drop in each eye at a visit.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change from baseline in near VA [Baseline]
Percentage of subjects with 3-line gains in near VA at various time points
Secondary Outcome Measures
- Change from baseline in distance VA [From baseline through hour 9 at each study visit]
Percentage of subjects with 1-line loss in distance VA at various time points
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Global Research Management, Inc. | Glendale | California | United States | 91204 |
2 | Eye Research Foundation | Newport Beach | California | United States | 92663 |
3 | Total Eye Care, PA | Memphis | Tennessee | United States | 38119 |
Sponsors and Collaborators
- Visus Therapeutics
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VT-001