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

Brimonidine tartrate 0.025% / ketotifen fumarate 0.035% combination ophthalmic solution, n = 75 for Allergic Eye

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

Study Summary

This trial tested a drug combo vs its individual parts and a placebo to assess its effectiveness in treating allergic conjunctivitis.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Conjunctival Redness measured by Ocular Hyperemia Scale
Ocular Itching measured by Conjunctival Allergen Challenge Ocular Itching Scale

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
~1090

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Who is running the clinical trial?

Bausch & Lomb IncorporatedLead Sponsor
251 Previous Clinical Trials
57,229 Total Patients Enrolled

Frequently Asked Questions

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

What is the Federal Drug Administration's opinion on Ketotifen fumarate ophthalmic solution 0.035% (n = 75)?

"Ketotifen fumarate ophthalmic solution 0.035% (n = 75) is estimated to be a level 3 on the Power safety scale because it is a Phase 3 trial."

Answered by AI

Are we currently recruiting participants for this research?

"Although this specific trial is no longer seeking participants, information available on clinicaltrials.gov reveals that it was most recently edited on October 21st, 2022. At the moment, there are 21 other trials that are still recruiting patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination for the Treatment of Allergic Conjunctivitis
2022. "Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination for the Treatment of Allergic Conjunctivitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05579730.
~77 spots leftby Apr 2025
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