Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia
Study Details
Study Description
Brief Summary
Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Detailed Description
Multicenter, Double-Masked, Randomized, Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF Topical Ophthalmic Solution With Emmetropic Phakic and Pseudophakic Presbyopia
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: BRIMOCHOL™ PF A single drop in each eye at a visit. |
Drug: BRIMOCHOL™ PF
A single drop in each eye at a visit.
Other Names:
|
Active Comparator: Carbachol PF A single drop in each eye at a visit. |
Drug: Carbachol PF
A single drop in each eye at a visit.
Other Names:
|
Placebo Comparator: Vehicle A single drop in each eye at a visit. |
Drug: Vehicle
A single drop in each eye at a visit.
|
Outcome Measures
Primary Outcome Measures
- Change from baseline in near VA [Baseline Day 1]
Percentage of subjects with 3-line improvement in near VA without the loss of at least 1 line in distance VA
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 | Nature Coast Clinical Research | Crystal River | Florida | United States | 34429 |
Sponsors and Collaborators
- Visus Therapeutics
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VT-003