A Phase 3 interventional study of BRIMOCHOL™ PF and Carbachol PF in Presbyopia, sponsored by Visus Therapeutics. Completed at 15 sites in United States. Open to participants aged 45 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by Visus Therapeutics · Phase 3, Interventional, and Treatment
Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia
Multicenter, Double-Masked, Randomized, Safety and Efficacy Study of BRIMOCHOL™ PF and Carbachol PF Topical Ophthalmic Solution 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 182 is above 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™ PF
A single drop in each eye at a visit.
Drug: Carbachol PF
A single drop in each eye at a visit.
Drug: 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
A single drop in each eye at a visit.
Also known as: brimonidine tartrate monotherapy
Proportion of Subjects With >=15 Letter Gain Without >=5 Letter Loss in Near Visual Acuity
Primary endpoint measure at hour 1 post-dose at study visit
Time frame: Day 1 Hour 1
| Milestone | B, C, BF | B, BF, C | C, B, BF | C, BF, B | BF, B, C | BF, C, B |
|---|---|---|---|---|---|---|
| Started | 31 | 30 | 30 | 30 | 31 | 30 |
| Completed | 31 | 30 | 30 | 29 | 31 | 30 |
| Not completed | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Randomization error | 0 | 0 | 0 | 1 | 0 | 0 |
| Milestone | B, C, BF | B, BF, C | C, B, BF | C, BF, B | BF, B, C | BF, C, B |
|---|---|---|---|---|---|---|
| Started | 31 | 30 | 30 | 29 | 31 | 30 |
| Completed | 31 | 30 | 30 | 29 | 30 | 28 |
| Not completed | 0 | 0 | 0 | 0 | 1 | 2 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 1 | 1 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 1 |
| Milestone | B, C, BF | B, BF, C | C, B, BF | C, BF, B | BF, B, C | BF, C, B |
|---|---|---|---|---|---|---|
| Started | 31 | 30 | 30 | 29 | 30 | 28 |
| Completed | 30 | 30 | 29 | 29 | 30 | 28 |
| Not completed | 1 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Inclusion criteria | 1 | 0 | 1 | 0 | 0 | 0 |
| Milestone | B, C, BF | B, BF, C | C, B, BF | C, BF, B | BF, B, C | BF, C, B |
|---|---|---|---|---|---|---|
| Started | 30 | 30 | 29 | 29 | 30 | 28 |
| Completed | 29 | 29 | 29 | 28 | 30 | 28 |
| Not completed | 1 | 1 | 0 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 1 | 0 | 0 |
| Milestone | B, C, BF | B, BF, C | C, B, BF | C, BF, B | BF, B, C | BF, C, B |
|---|---|---|---|---|---|---|
| Started | 29 | 29 | 29 | 28 | 30 | 28 |
| Completed | 29 | 29 | 29 | 28 | 30 | 28 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
Primary endpoint measure at hour 1 post-dose at study visit
| Percentage of participants | BRIMOCHOL™ PF | Carbachol PF | Brimonidine Tartrate |
|---|---|---|---|
| Proportion of Subjects With >=15 Letter Gain Without >=5 Letter Loss in Near Visual Acuity | 49.4 (41.9 to 57.0) | 35.0 (28.0 to 42.5) | 22.7 (16.8 to 29.6) |
Collected over 45 Days. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BRIMOCHOL™ PF | 0/178 (0%) | 1/178 (0.6%) | 37/178 (20.8%) |
| Carbachol PF | 0/177 (0%) | 0/177 (0%) | 24/177 (13.6%) |
| Brimonidine Tartrate | 0/176 (0%) | 0/176 (0%) | 2/176 (1.1%) |
| Event | BRIMOCHOL™ PF | Carbachol PF | Brimonidine Tartrate |
|---|---|---|---|
| NephrolithiasisRenal and urinary disorders | 1/178 | 0/177 | 0/176 |
| Event | BRIMOCHOL™ PF | Carbachol PF | Brimonidine Tartrate |
|---|---|---|---|
| Eye IrritationEye disorders | 25/178 | 20/177 | 1/176 |
| HeadacheNervous system disorders | 16/178 | 5/177 | 1/176 |
| Age, Continuous(Years) | All Subjects |
|---|---|
| Mean | 55 ± 6 |
| Sex: Female, Male(Participants) | All Subjects |
|---|---|
| Female | 113 |
| Male | 69 |
| Ethnicity (NIH/OMB)(Participants) | All Subjects |
|---|---|
| Hispanic or Latino | 47 |
| Not Hispanic or Latino | 135 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | All Subjects |
|---|---|
| American Indian or Alaska Native | 2 |
| Asian | 15 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 46 |
| White | 116 |
| More than one race | 2 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(Participants) | All Subjects |
|---|---|
| United States | 182 |
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Visus Therapeutics