Trial · NCT04774237

Safety and Efficacy Study of BRIMOCHOL™, BRIMOCHOL™ F, and Carbachol in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia

NCT04774237, Phase 2, Completed, Visus Therapeutics; results first posted 2025-02-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy Study of BRIMOCHOL™, BRIMOCHOL™ F, and Carbachol in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia. Trials, record NCT04774237. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04774237

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy Study of BRIMOCHOL™, BRIMOCHOL™ F, and Carbachol in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia
NCT number: NCT04774237
Status: Completed
Phases: Phase 2
Enrollment: 18 participants, actual
Lead sponsor: Visus Therapeutics
Conditions: Presbyopia
Interventions: BRIMOCHOL™, BRIMOCHOL™ F, Carbachol
First posted: 2021-03-01
Last updated: 2026-03-27
Results first posted: 2025-02-05

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Proportion of Subjects With a >=15 Letter Gain Without a < 5 Letter Loss in Near Visual Acuity	Day 1, Hour 1 post-dose	Primary Endpoint measured at Hour 1 post-dose at Study Visit - a Single drop Cohort
Secondary	Change From Baseline ETDRS Letters Score in Distance Visual Acuity	Day 1, Hour 1 post-dose	Secondary Endpoint measured at Hour 1 post-dose at Study Visit - a Single drop Cohort

Source ClinicalTrials.gov

Outcomes2

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 a >=15 Letter Gain Without a < 5 Letter Loss in Near Visual Acuity	Day 1, Hour 1 post-dose		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline ETDRS Letters Score in Distance Visual Acuity	Day 1, Hour 1 post-dose		ETDRS letters	MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Proportion of Subjects With a >=15 Letter Gain Without a < 5 Letter Loss in Near Visual Acuity	BRIMOCHOL	15		Participants
Proportion of Subjects With a >=15 Letter Gain Without a < 5 Letter Loss in Near Visual Acuity	BRIMOCHOL PF	15		Participants
Proportion of Subjects With a >=15 Letter Gain Without a < 5 Letter Loss in Near Visual Acuity	Carbachol PF	16		Participants
Change From Baseline ETDRS Letters Score in Distance Visual Acuity	BRIMOCHOL™	2.4	Standard Deviation 3.39	ETDRS letters
Change From Baseline ETDRS Letters Score in Distance Visual Acuity	BRIMOCHOL™ F	2.8	Standard Deviation 3.28	ETDRS letters
Change From Baseline ETDRS Letters Score in Distance Visual Acuity	Carbachol	3.1	Standard Deviation 2.86	ETDRS letters

Source ClinicalTrials.gov

Participant flow90

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Visit 2 First Intervention	STARTED	B, C, BF	2
Visit 2 First Intervention	STARTED	B, BF, C	5
Visit 2 First Intervention	STARTED	C, B, BF	3
Visit 2 First Intervention	STARTED	C, BF, B	2
Visit 2 First Intervention	STARTED	BF, B, C	3
Visit 2 First Intervention	STARTED	BF, C, B	3
Visit 2 First Intervention	COMPLETED	B, C, BF	2
Visit 2 First Intervention	COMPLETED	B, BF, C	5
Visit 2 First Intervention	COMPLETED	C, B, BF	3
Visit 2 First Intervention	COMPLETED	C, BF, B	2

1 to 10 of 90Source ClinicalTrials.gov

See all 90 participant flow

Adverse events6

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	1	17	1
other	Eye irritation	Eye disorders	BRIMOCHOL PF	0	18	0
other	Eye irritation	Eye disorders	Carbachol PF	0	17	0
other	Eye pain	Eye disorders	BRIMOCHOL	0	17	0
other	Eye pain	Eye disorders	BRIMOCHOL PF	1	18	1
other	Eye pain	Eye disorders	Carbachol PF	0	17	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	1	17
Total, all-cause mortality	BRIMOCHOL PF	1	18
Total, all-cause mortality	Carbachol PF	0	17
Total, other adverse events	BRIMOCHOL	1	17
Total, other adverse events	BRIMOCHOL PF	1	18
Total, other adverse events	Carbachol PF	0	17
Total, serious adverse events	BRIMOCHOL	0	17
Total, serious adverse events	BRIMOCHOL PF	0	18
Total, serious adverse events	Carbachol PF	0	17

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT04774237

GET https://conductscience.org/api/trials/v1/NCT04774237/flow?page=2

API reference For AI assistants