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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

Study 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

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

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
Ketotifen fumarate ophthalmic solution 0.035% (n = 56)
2022
Completed Phase 3
~230
Experimental: Vehicle ophthalmic solution (n = 56)
2022
Completed Phase 3
~230
Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution
2022
Completed Phase 3
~230
Brimonidine tartrate ophthalmic solution 0.025% (n = 56)
2022
Completed Phase 3
~230

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Who is running the clinical trial?

Bausch & Lomb IncorporatedLead Sponsor
251 Previous Clinical Trials
57,188 Total Patients Enrolled
Dan DonatelloStudy DirectorBausch & Lomb Incorporated

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people with the required medical conditions able to sign up for this testing program?

"Unfortunately, this particular clinical trial is not seeking any more participants as of right now. According to the clinicaltrials.gov website, this study was first posted on October 22nd, 2022 and was last edited on October 19th, 2022. However, there are 21 other trials that are still looking for patients."

Answered by AI

Is the FDA's decision on Brimonidine tartrate ophthalmic solution 0.025% (n = 56) final?

"Brimonidine tartrate ophthalmic solution 0.025% (n = 56) is estimated to be a safe 3 because this is a Phase 3 trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination in Adults With Seasonal Allergic Conjunctivitis
2022. "Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination in Adults With Seasonal Allergic Conjunctivitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05591755.
~91 spots leftby Apr 2025
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