Trial · NCT05270863
Safety and Efficacy Study BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic or Pseudophakic Presbyopia
NCT05270863, Phase 3, Completed, Visus Therapeutics; results first posted 2024-09-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy Study BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic or Pseudophakic Presbyopia. Trials, record NCT05270863. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05270863
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study BRIMOCHOL™ PF and Carbachol PF in Subjects With Emmetropic Phakic or Pseudophakic Presbyopia
- NCT number
- NCT05270863
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 182 participants, actual
- Lead sponsor
- Visus Therapeutics
- Conditions
- Presbyopia
- Interventions
- BRIMOCHOL™ PF, Carbachol PF, Brimonidine tartrate
- First posted
- 2022-03-08
- Last updated
- 2024-10-15
- Results first posted
- 2024-09-05
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Subjects With >=15 Letter Gain Without >=5 Letter Loss in Near Visual Acuity | Day 1 Hour 1 | Primary endpoint measure at hour 1 post-dose at study visit |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Subjects With >=15 Letter Gain Without >=5 Letter Loss in Near Visual Acuity | Day 1 Hour 1 | All participants who received at least one dose of study treatment (mITT) | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Subjects With >=15 Letter Gain Without >=5 Letter Loss in Near Visual Acuity | BRIMOCHOL™ PF | 49.4 | 95% Confidence Interval 41.9 to 57.0 | Percentage of participants | |
| Proportion of Subjects With >=15 Letter Gain Without >=5 Letter Loss in Near Visual Acuity | Carbachol PF | 35.0 | 95% Confidence Interval 28.0 to 42.5 | Percentage of participants | |
| Proportion of Subjects With >=15 Letter Gain Without >=5 Letter Loss in Near Visual Acuity | Brimonidine Tartrate | 22.7 | 95% Confidence Interval 16.8 to 29.6 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow90
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Visit 2 First Intervention | STARTED | B, C, BF | 31 | |
| Visit 2 First Intervention | STARTED | B, BF, C | 30 | |
| Visit 2 First Intervention | STARTED | C, B, BF | 30 | |
| Visit 2 First Intervention | STARTED | C, BF, B | 30 | |
| Visit 2 First Intervention | STARTED | BF, B, C | 31 | |
| Visit 2 First Intervention | STARTED | BF, C, B | 30 | |
| Visit 2 First Intervention | COMPLETED | B, C, BF | 31 | |
| Visit 2 First Intervention | COMPLETED | B, BF, C | 30 | |
| Visit 2 First Intervention | COMPLETED | C, B, BF | 30 | |
| Visit 2 First Intervention | COMPLETED | C, BF, B | 29 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 participant flowAdverse events9
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Eye Irritation | Eye disorders | BRIMOCHOL™ PF | 25 | 178 | |
| other | Eye Irritation | Eye disorders | Carbachol PF | 20 | 177 | |
| other | Eye Irritation | Eye disorders | Brimonidine Tartrate | 1 | 176 | |
| other | Headache | Nervous system disorders | BRIMOCHOL™ PF | 16 | 178 | |
| other | Headache | Nervous system disorders | Carbachol PF | 5 | 177 | |
| other | Headache | Nervous system disorders | Brimonidine Tartrate | 1 | 176 | |
| serious | Nephrolithiasis | Renal and urinary disorders | BRIMOCHOL™ PF | 1 | 178 | 1 |
| serious | Nephrolithiasis | Renal and urinary disorders | Carbachol PF | 0 | 177 | 0 |
| serious | Nephrolithiasis | Renal and urinary disorders | Brimonidine Tartrate | 0 | 176 | 0 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BRIMOCHOL™ PF | 0 | 178 |
| Total, all-cause mortality | Carbachol PF | 0 | 177 |
| Total, all-cause mortality | Brimonidine Tartrate | 0 | 176 |
| Total, other adverse events | BRIMOCHOL™ PF | 37 | 178 |
| Total, other adverse events | Carbachol PF | 24 | 177 |
| Total, other adverse events | Brimonidine Tartrate | 2 | 176 |
| Total, serious adverse events | BRIMOCHOL™ PF | 1 | 178 |
| Total, serious adverse events | Carbachol PF | 0 | 177 |
| Total, serious adverse events | Brimonidine Tartrate | 0 | 176 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05270863
GET https://conductscience.org/api/trials/v1/NCT05270863/flow?page=2