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Antihistamine/Mast Cell Stabilizer Combination and Alpha-2 Adrenergic Agonist

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

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 minutes & 8 hours post-dose from conjunctival allergen challenge (cac) model
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial tests a new eye drop that combines two drugs to treat eye allergies. It aims to see if the combination works better than each drug alone. The treatment targets people with allergic conjunctivitis, aiming to reduce redness and itching.

Eligible Conditions
  • Allergic Eye

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 minutes & 8 hours post-dose from conjunctival allergen challenge (cac) model
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 minutes & 8 hours post-dose from conjunctival allergen challenge (cac) model for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Conjunctival Redness measured by Ocular Hyperemia Scale
Ocular Itching measured by Conjunctival Allergen Challenge Ocular Itching Scale

Awards & Highlights

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

Trial Design

4Treatment groups
Experimental Treatment
Group I: Vehicle ophthalmic solution (n = 75)Experimental Treatment4 Interventions
Group II: Ketotifen fumarate ophthalmic solution 0.035% (n = 75)Experimental Treatment4 Interventions
Group III: Brimonidine tartrate ophthalmic solution 0.025% (n = 75)Experimental Treatment4 Interventions
Group IV: Brimonidine tartrate 0.025% / ketotifen fumarate 0.035% combination ophthalmic solution, n = 75Experimental Treatment4 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brimonidine tartrate ophthalmic solution 0.025%
2022
Completed Phase 4
~230
Brimonidine tartrate 0.025% / ketotifen fumarate 0.035% combo
2022
Completed Phase 3
~190
Ketotifen fumarate ophthalmic solution 0.035%
2022
Completed Phase 3
~190
Vehicle ophthalmic solution
2022
Completed Phase 3
~1740

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Who is running the clinical trial?

Bausch & Lomb IncorporatedLead Sponsor
257 Previous Clinical Trials
58,043 Total Patients Enrolled
~61 spots leftby Dec 2025
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