Clinical trial
Multicenter, Double-Masked, Randomized, Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF Topical Ophthalmic Solution With Emmetropic Phakic and Pseudophakic Presbyopia
Name
VT-003
Description
Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia
Trial arms
Trial start
2022-03-15
Estimated PCD
2024-12-31
Trial end
2024-12-31
Status
Recruiting
Phase
Early phase I
Treatment
BRIMOCHOL™ PF
A single drop in each eye at a visit.
Arms:
BRIMOCHOL™ PF
Other names:
carbachol/brimonidine tartrate
Carbachol PF
A single drop in each eye at a visit.
Arms:
Carbachol PF
Other names:
carbachol monotherapy
Vehicle
A single drop in each eye at a visit.
Arms:
Vehicle
Size
450
Primary endpoint
Change from baseline in near VA
Baseline Day 1
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 450, 'type': 'ESTIMATED'}}
Updated at
2024-04-23
1 organization
3 products
1 indication
Organization
Visus TherapeuticsProduct
BrimocholIndication
PresbyopiaProduct
CarbacholProduct
Vehicle