Trial · NCT05579730

Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination for the Treatment of Allergic Conjunctivitis

NCT05579730, Phase 3, Completed, Bausch & Lomb Incorporated; results first posted 2025-02-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination for the Treatment of Allergic Conjunctivitis. Trials, record NCT05579730. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05579730

On this page

Trial

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

Title: Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination for the Treatment of Allergic Conjunctivitis
NCT number: NCT05579730
Status: Completed
Phases: Phase 3
Enrollment: 188 participants, actual
Lead sponsor: Bausch & Lomb Incorporated
Conditions: Allergic Conjunctivitis
Interventions: Brimonidine tartrate 0.025%/ketotifen fumarate 0.035%, Brimonidine Tartrate 0.025%, Ketotifen Fumarate 0.035%, Vehicle
First posted: 2022-10-14
Last updated: 2025-02-14
Results first posted: 2025-02-14

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Ocular Itching	Assessed at Visit 4b on day 1 (duration of action CAC at 8 hours post-instillation of study medication) and Visit 5 on day 15 (onset of action CAC at 15 minutes post-instillation of study medication).	Ocular itching score (measured on a 0-4 unit scale, allowing half-unit increments; average score of the subject's two eyes) assessed by the subjects at 3 (±1), 5 (±1), and 7 (±1) minutes post-CAC.
Primary	Conjunctival Redness	Assessed at Visit 4b on day 1 (duration of action CAC at 8 hours post-instillation of study medication) and Visit 5 on day 15 (onset of action CAC at 15 minutes post-instillation of study medication).	Conjunctival redness score (measured on a 0-4unit scale, allowing half-unit increments; average score of the subject's two eyes) assessed by investigator at 7 (±1), 15 (±1), and 20 (±1) minutes post-CAC.

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	Ocular Itching	Assessed at Visit 4b on day 1 (duration of action CAC at 8 hours post-instillation of study medication) and Visit 5 on day 15 (onset of action CAC at 15 minutes post-instillation of study medication).		score on a scale	MEAN
PRIMARY	Conjunctival Redness	Assessed at Visit 4b on day 1 (duration of action CAC at 8 hours post-instillation of study medication) and Visit 5 on day 15 (onset of action CAC at 15 minutes post-instillation of study medication).		score on a scale	MEAN

Source ClinicalTrials.gov

Results by group48

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

Outcome	Group	Category	Value	Spread	Units
Ocular Itching	Combination	Visit 4b, 3 min Post-CAC	1.176	Standard Error 0.1464	score on a scale
Ocular Itching	Ketotifen Fumarate	Visit 4b, 3 min Post-CAC	1.708	Standard Error 0.1487	score on a scale
Ocular Itching	Brimonidine Tartrate	Visit 4b, 3 min Post-CAC	2.426	Standard Error 0.1330	score on a scale
Ocular Itching	Vehicle	Visit 4b, 3 min Post-CAC	2.362	Standard Error 0.1512	score on a scale
Ocular Itching	Combination	Visit 4b, 5 min Post-CAC	1.287	Standard Error 0.1507	score on a scale
Ocular Itching	Ketotifen Fumarate	Visit 4b, 5 min Post-CAC	1.688	Standard Error 0.1519	score on a scale
Ocular Itching	Brimonidine Tartrate	Visit 4b, 5 min Post-CAC	2.638	Standard Error 0.1155	score on a scale
Ocular Itching	Vehicle	Visit 4b, 5 min Post-CAC	2.712	Standard Error 0.1427	score on a scale
Ocular Itching	Combination	Visit 4b, 7 min Post-CAC	1.181	Standard Error 0.1462	score on a scale
Ocular Itching	Ketotifen Fumarate	Visit 4b, 7 min Post-CAC	1.656	Standard Error 0.1532	score on a scale

1 to 10 of 48Source ClinicalTrials.gov

See all 48 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Combination	47
Overall Study	STARTED	Ketotifen Fumarate	48
Overall Study	STARTED	Brimonidine Tartrate	47
Overall Study	STARTED	Vehicle	46
Overall Study	COMPLETED	Combination	45
Overall Study	COMPLETED	Ketotifen Fumarate	45
Overall Study	COMPLETED	Brimonidine Tartrate	47
Overall Study	COMPLETED	Vehicle	44
Overall Study	NOT COMPLETED	Combination	2
Overall Study	NOT COMPLETED	Ketotifen Fumarate	3

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events56

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
other	Visual Acuity reduced	Eye disorders	Combination	1	47
other	Visual Acuity reduced	Eye disorders	Ketotifen Fumarate	0	48
other	Visual Acuity reduced	Eye disorders	Brimonidine Tartrate	1	47
other	Visual Acuity reduced	Eye disorders	Vehicle	1	46
other	Conjunctival haemorrhage	Eye disorders	Combination	0	47
other	Conjunctival haemorrhage	Eye disorders	Ketotifen Fumarate	0	48
other	Conjunctival haemorrhage	Eye disorders	Brimonidine Tartrate	0	47
other	Conjunctival haemorrhage	Eye disorders	Vehicle	1	46
other	Conjunctivitis allergic	Eye disorders	Combination	0	47
other	Conjunctivitis allergic	Eye disorders	Ketotifen Fumarate	0	48

1 to 10 of 56Source ClinicalTrials.gov

See all 56 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Combination	0	47
Total, all-cause mortality	Ketotifen Fumarate	0	48
Total, all-cause mortality	Brimonidine Tartrate	0	47
Total, all-cause mortality	Vehicle	0	46
Total, other adverse events	Combination	3	47
Total, other adverse events	Ketotifen Fumarate	6	48
Total, other adverse events	Brimonidine Tartrate	6	47
Total, other adverse events	Vehicle	4	46
Total, serious adverse events	Combination	0	47
Total, serious adverse events	Ketotifen Fumarate	0	48

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

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.

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