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

NCT05579730 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2025-02-14

Study results available
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Summary

To evaluate the efficacy of Combo (Drug Product Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution) compared to its individual components and vehicle in a population of subjects with allergic conjunctivitis:

Conditions

  • Allergic Conjunctivitis

Interventions

DRUG

Brimonidine tartrate 0.025%/ketotifen fumarate 0.035%

combination ophthalmic solution

DRUG

Brimonidine Tartrate 0.025%

ophthalmic Solution

DRUG

Ketotifen Fumarate 0.035%

ophthalmic Solution

DRUG

Vehicle

ophthalmic Solution

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-12
Primary Completion
2023-07-22
Completion
2023-07-22
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 NCT05579730 on ClinicalTrials.gov