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Antihistamine/Mast Cell Stabilizer Combination

Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution (n = 56) for Seasonal Allergy

Phase 3
Waitlist Available
Research Sponsored by Bausch & Lomb Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 480 minutes post-instillation of assigned ip
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial tests if a treatment combo works better than its individual components to treat seasonal allergy eye irritation.

Eligible Conditions
  • Seasonal Allergy Eyes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 480 minutes post-instillation of assigned ip
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 480 minutes post-instillation of assigned ip for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ocular itching score subject
Slit lamp biomicroscope (physical object)
Secondary study objectives
Chemosis evaluated
Lid swelling measured by Eyelid Swelling Scale
Eye

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Vehicle ophthalmic solution (n = 56)Experimental Treatment1 Intervention
Group II: Ketotifen fumarate ophthalmic solution 0.035% (n = 56)Experimental Treatment1 Intervention
Group III: Brimonidine tartrate ophthalmic solution 0.025% (n = 56)Experimental Treatment1 Intervention
Group IV: Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution (n = 56)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution
2022
Completed Phase 3
~230
Ketotifen fumarate ophthalmic solution 0.035% (n = 56)
2022
Completed Phase 3
~230
Brimonidine tartrate ophthalmic solution 0.025% (n = 56)
2022
Completed Phase 3
~230
Experimental: Vehicle ophthalmic solution (n = 56)
2022
Completed Phase 3
~230

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Who is running the clinical trial?

Bausch & Lomb IncorporatedLead Sponsor
257 Previous Clinical Trials
58,002 Total Patients Enrolled
Dan DonatelloStudy DirectorBausch & Lomb Incorporated
~76 spots leftby Dec 2025
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