Trial · NCT05591755

Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination in Adults With Seasonal Allergic Conjunctivitis

NCT05591755, Phase 3, Completed, Bausch & Lomb Incorporated; results first posted 2025-07-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination in Adults With Seasonal Allergic Conjunctivitis. Trials, record NCT05591755. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05591755

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 in Adults With Seasonal Allergic Conjunctivitis
NCT number: NCT05591755
Status: Completed
Phases: Phase 3
Enrollment: 229 participants, actual
Lead sponsor: Bausch & Lomb Incorporated
Conditions: Seasonal Allergic Conjunctivitis
Interventions: Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution, Ketotifen fumarate ophthalmic solution 0.035%, Brimonidine tartrate ophthalmic solution 0.025%, Experimental: Vehicle ophthalmic solution
First posted: 2022-10-24
Last updated: 2025-07-01
Results first posted: 2025-07-01

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Ocular Itching Symptom Score	Assessed up to 480 minutes post-instillation of assigned IP	Ocular itching score evaluated by the subject at 10(±1), 30(±1), 60(±5), 360(±5), 420(±5), and 480(±5) minutes post-instillation of assigned IP at Visit 2 (0-4 scale, allowing half unit increments), with 4 is the worse outcome.
Primary	Ocular Redness Measured by Ocular Itching Scale	Assessed up to 480 minutes post-instillation of assigned IP	Ocular redness evaluated by the Investigator using slit lamp at 10(±1), 30(±1), 60(±5), 360(±5), 420(±5), and 480(±5) minutes post-instillation of assigned IP at Visit 2 (0-4 scale, allowing half unit increments), with 4 being the worse outcome.
Secondary	Tearing Measured by Watery Eyes Scale	up to 480 minutes post-instillation of assigned IP	Tearing evaluated by the subject at 10(±1), 30(±1), 60(±5), 360(±5), 420(±5), and 480(±5) minutes post-instillation of assigned IP at Visit 2 (0-4 scale, NOT allowing half unit increments), with 4 being the worse outcome.
Secondary	Lid Swelling Measured by Eyelid Swelling Scale	up to 480 minutes post-instillation of assigned IP	Lid swelling evaluated by the subject at 10(±1), 30(±1), 60(±5), 360(±5), 420(±5), and 480(±5) minutes post-instillation of assigned IP at Visit 2 (0-3 scale, NOT allowing half unit increments), with 3 being the worst outcome
Secondary	Chemosis Evaluated	up to 480 minutes post-instillation of assigned IP	Chemosis evaluated by the Investigator using slit lamp at 10(±1), 30(±1), 60(±5), 360(±5), 420(±5), and 480(±5) minutes post-instillation of assigned IP at Visit 2 (0-4 scale, allowing half unit increments), with 4 being the worse outcome.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Ocular Itching Symptom Score	Assessed up to 480 minutes post-instillation of assigned IP	score on a scale	MEAN
PRIMARY	Ocular Redness Measured by Ocular Itching Scale	Assessed up to 480 minutes post-instillation of assigned IP	score on a scale	MEAN
SECONDARY	Tearing Measured by Watery Eyes Scale	up to 480 minutes post-instillation of assigned IP	score on a scale	MEAN
SECONDARY	Lid Swelling Measured by Eyelid Swelling Scale	up to 480 minutes post-instillation of assigned IP	score on a scale	MEAN
SECONDARY	Chemosis Evaluated	up to 480 minutes post-instillation of assigned IP	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group232

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

Outcome	Group	Category	Value	Spread	Units
Ocular Itching Symptom Score	Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution	Visit 2, Before Qualification ABC	0.175	Standard Deviation 0.6031	score on a scale
Ocular Itching Symptom Score	Ketotifen Fumarate Ophthalmic Solution 0.035%	Visit 2, Before Qualification ABC	0.085	Standard Deviation 0.3136	score on a scale
Ocular Itching Symptom Score	Brimonidine Tartrate Ophthalmic Solution 0.025%	Visit 2, Before Qualification ABC	0.267	Standard Deviation 0.7549	score on a scale
Ocular Itching Symptom Score	Vehicle Ophthalmic Solution	Visit 2, Before Qualification ABC	0.098	Standard Deviation 0.3493	score on a scale
Ocular Itching Symptom Score	Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution	Visit 2, 90 Minutes during Qualification ABC (Baseline)	2.728	Standard Deviation 0.5830	score on a scale
Ocular Itching Symptom Score	Ketotifen Fumarate Ophthalmic Solution 0.035%	Visit 2, 90 Minutes during Qualification ABC (Baseline)	2.719	Standard Deviation 0.5310	score on a scale
Ocular Itching Symptom Score	Brimonidine Tartrate Ophthalmic Solution 0.025%	Visit 2, 90 Minutes during Qualification ABC (Baseline)	2.659	Standard Deviation 0.4581	score on a scale
Ocular Itching Symptom Score	Vehicle Ophthalmic Solution	Visit 2, 90 Minutes during Qualification ABC (Baseline)	2.647	Standard Deviation 0.5174	score on a scale
Ocular Itching Symptom Score	Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution	Visit 2, 10 min Post-Instillation	1.807	Standard Deviation 1.0501	score on a scale
Ocular Itching Symptom Score	Ketotifen Fumarate Ophthalmic Solution 0.035%	Visit 2, 10 min Post-Instillation	1.808	Standard Deviation 0.8712	score on a scale

1 to 10 of 232Source ClinicalTrials.gov

See all 232 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution	58
Overall Study	STARTED	Ketotifen Fumarate Ophthalmic Solution 0.035%	57
Overall Study	STARTED	Brimonidine Tartrate Ophthalmic Solution 0.025%	58
Overall Study	STARTED	Vehicle Ophthalmic Solution	56
Overall Study	COMPLETED	Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution	57
Overall Study	COMPLETED	Ketotifen Fumarate Ophthalmic Solution 0.035%	56
Overall Study	COMPLETED	Brimonidine Tartrate Ophthalmic Solution 0.025%	56
Overall Study	COMPLETED	Vehicle Ophthalmic Solution	56
Overall Study	NOT COMPLETED	Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution	1
Overall Study	NOT COMPLETED	Ketotifen Fumarate Ophthalmic Solution 0.035%	1

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events20

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	Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution	1	57
other	Visual acuity reduced	Eye disorders	Ketotifen Fumarate Ophthalmic Solution 0.035%	2	56
other	Visual acuity reduced	Eye disorders	Brimonidine Tartrate Ophthalmic Solution 0.025%	2	58
other	Visual acuity reduced	Eye disorders	Vehicle Ophthalmic Solution	2	56
other	Ocular hyperaemia	Eye disorders	Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution	0	57
other	Ocular hyperaemia	Eye disorders	Ketotifen Fumarate Ophthalmic Solution 0.035%	2	56
other	Ocular hyperaemia	Eye disorders	Brimonidine Tartrate Ophthalmic Solution 0.025%	0	58
other	Ocular hyperaemia	Eye disorders	Vehicle Ophthalmic Solution	1	56
other	Eyelid exfoliation	Eye disorders	Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution	0	57
other	Eyelid exfoliation	Eye disorders	Ketotifen Fumarate Ophthalmic Solution 0.035%	0	56

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution	0	57
Total, all-cause mortality	Ketotifen Fumarate Ophthalmic Solution 0.035%	0	56
Total, all-cause mortality	Brimonidine Tartrate Ophthalmic Solution 0.025%	0	58
Total, all-cause mortality	Vehicle Ophthalmic Solution	0	56
Total, other adverse events	Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution	1	57
Total, other adverse events	Ketotifen Fumarate Ophthalmic Solution 0.035%	6	56
Total, other adverse events	Brimonidine Tartrate Ophthalmic Solution 0.025%	2	58
Total, other adverse events	Vehicle Ophthalmic Solution	5	56
Total, serious adverse events	Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution	0	57
Total, serious adverse events	Ketotifen Fumarate Ophthalmic Solution 0.035%	0	56

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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