Phase 2
Completed N=18
Safety and Efficacy Study of BRIMOCHOL™, BRIMOCHOL™ F, and Carbachol in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia
Source: ClinicalTrials.gov NCT04774237 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcomePrimary: Proportion of Subjects With a >=15 Letter Gain Without a < 5 Letter Loss in Near Visual Acuity — 15; 15; 16 Participants
Summary
Safety and Efficacy Study of BRIMOCHOL™ vs. BRIMOCHOL™ F vs. Carbachol Monotherapy Topical Ophthalmic Solutions in Subjects with Emmetropic Phakic and Pseudophakic Presbyopia
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects With a >=15 Letter Gain Without a < 5 Letter Loss in Near Visual Acuity |
15; 15; 16 | — |
| SECONDARY Change From Baseline ETDRS Letters Score in Distance Visual Acuity |
2.4; 2.8; 3.1 | — |
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
Data sourced from ClinicalTrials.gov (NCT04774237). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.