A Phase 2 interventional study of BRIMOCHOL™ and BRIMOCHOL™ F in Presbyopia, sponsored by Visus Therapeutics. Completed at 3 sites in United States. Open to participants aged 45 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Visus Therapeutics · Phase 2, Interventional, and Treatment
Safety and Efficacy Study of BRIMOCHOL™ vs. BRIMOCHOL™ F vs. Carbachol Monotherapy Topical Ophthalmic Solutions in Subjects with Emmetropic Phakic and Pseudophakic Presbyopia
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
324 studies on the registry are indexed under Presbyopia; 33 are open to participants now.
This study's enrollment of 18 is below the median of 61 across 265 interventional studies indexed under Presbyopia.
Browse Presbyopia studies →Visus Therapeutics is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A single drop in each eye at a visit.
Drug: BRIMOCHOL™
A single drop in each eye at a visit.
Drug: BRIMOCHOL™ F
A single drop in each eye at a visit.
Drug: Carbachol
A single drop in each eye at a visit.
Also known as: carbachol/brimonidine tartrate
A single drop in each eye at a visit.
Also known as: carbachol/brimonidine tartrate
A single drop in each eye at a visit.
Also known as: carbachol monotherapy
Proportion of Subjects With a >=15 Letter Gain Without a < 5 Letter Loss in Near Visual Acuity
Primary Endpoint measured at Hour 1 post-dose at Study Visit - a Single drop Cohort
Time frame: Day 1, Hour 1 post-dose
Change From Baseline ETDRS Letters Score in Distance Visual Acuity
Secondary Endpoint measured at Hour 1 post-dose at Study Visit - a Single drop Cohort
Time frame: Day 1, Hour 1 post-dose
| Milestone | B, C, BF | B, BF, C | C, B, BF | C, BF, B | BF, B, C | BF, C, B |
|---|---|---|---|---|---|---|
| Started | 2 | 5 | 3 | 2 | 3 | 3 |
| Completed | 2 | 5 | 3 | 2 | 2 | 3 |
| Not completed | 0 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 1 | 0 |
| Milestone | B, C, BF | B, BF, C | C, B, BF | C, BF, B | BF, B, C | BF, C, B |
|---|---|---|---|---|---|---|
| Started | 2 | 5 | 3 | 2 | 2 | 3 |
| Completed | 2 | 5 | 3 | 2 | 2 | 3 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | B, C, BF | B, BF, C | C, B, BF | C, BF, B | BF, B, C | BF, C, B |
|---|---|---|---|---|---|---|
| Started | 2 | 5 | 3 | 2 | 2 | 3 |
| Completed | 2 | 5 | 3 | 2 | 2 | 3 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | B, C, BF | B, BF, C | C, B, BF | C, BF, B | BF, B, C | BF, C, B |
|---|---|---|---|---|---|---|
| Started | 2 | 5 | 3 | 2 | 2 | 3 |
| Completed | 2 | 5 | 3 | 2 | 2 | 3 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | B, C, BF | B, BF, C | C, B, BF | C, BF, B | BF, B, C | BF, C, B |
|---|---|---|---|---|---|---|
| Started | 2 | 5 | 3 | 2 | 2 | 3 |
| Completed | 2 | 5 | 3 | 2 | 2 | 3 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
Primary Endpoint measured at Hour 1 post-dose at Study Visit - a Single drop Cohort
| Participants | BRIMOCHOL | BRIMOCHOL PF | Carbachol PF |
|---|---|---|---|
| Proportion of Subjects With a >=15 Letter Gain Without a < 5 Letter Loss in Near Visual Acuity | 15 | 15 | 16 |
Secondary Endpoint measured at Hour 1 post-dose at Study Visit - a Single drop Cohort
| ETDRS letters | BRIMOCHOL™ | BRIMOCHOL™ F | Carbachol |
|---|---|---|---|
| Change From Baseline ETDRS Letters Score in Distance Visual Acuity | 2.4 ± 3.39 | 2.8 ± 3.28 | 3.1 ± 2.86 |
Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BRIMOCHOL | 0/17 (0%) | 0/17 (0%) | 1/17 (5.9%) |
| BRIMOCHOL PF | 0/18 (0%) | 0/18 (0%) | 1/18 (5.6%) |
| Carbachol PF | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Event | BRIMOCHOL | BRIMOCHOL PF | Carbachol PF |
|---|---|---|---|
| Eye irritationEye disorders | 1/17 | 0/18 | 0/17 |
| Eye painEye disorders | 0/17 | 1/18 | 0/17 |
| Age, Continuous(Years) | Single Drop Cohort |
|---|---|
| Mean | 52.3 ± 4.31 |
| Sex: Female, Male(Participants) | Single Drop Cohort |
|---|---|
| Female | 7 |
| Male | 11 |
| Ethnicity (NIH/OMB)(Participants) | Single Drop Cohort |
|---|---|
| Hispanic or Latino | 7 |
| Not Hispanic or Latino | 11 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Single Drop Cohort |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 13 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Single Drop Cohort |
|---|---|
| United States | 18 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Visus Therapeutics