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

NCT05591755 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 229

Last updated 2025-07-01

Study results available
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Summary

To evaluate the efficacy of Combo compared to its individual components and compared to vehicle in a population of subjects with seasonal allergic conjunctivitis.

Conditions

  • Seasonal Allergic Conjunctivitis

Interventions

DRUG

Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution

Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution

DRUG

Ketotifen fumarate ophthalmic solution 0.035%

Ketotifen fumarate ophthalmic solution 0.035%

DRUG

Brimonidine tartrate ophthalmic solution 0.025%

Brimonidine tartrate ophthalmic solution 0.025%

DRUG

Experimental: Vehicle ophthalmic solution

Experimental: Vehicle ophthalmic solution

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-18
Primary Completion
2023-08-09
Completion
2023-08-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05591755 on ClinicalTrials.gov