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

Evaluation of Combination Drug Product Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution Compared to Its Components and Vehicle for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge Model

NCT05579730•Bausch & Lomb Incorporated

View on ClinicalTrials.gov

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:

Eligibility

Age

10 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects must:
•1. be at least 10 years of age of either sex and any race;
•2. provide written informed consent and sign a HIPAA form. Subjects who are under the age of 18 will need to sign an assent form as well as having a parent or legal guardian sign an informed consent;
•3. be willing and able to follow all instructions and attend all study visits;
•4. (If female and of childbearing potential) agree to have urine pregnancy testing performed at visits 2, 4a (must be negative) and at exit visit (Visit 5); must not be lactating; and must agree to use at least 1 medically acceptable form of birth control throughout the study duration, for at least 14 days prior to the first dose of investigational drug (Visit 4a) and for 1 month after the last dose of investigational drug (Visit 5). Acceptable forms of birth control are true abstinence (when this is in line with the preferred and usual lifestyle of the subject), spermicide with barrier, oral contraceptive, injectable or implantable method of contraception, transdermal contraceptive, intrauterine device, or surgical sterilization of male partner at least 3 months prior to the first dose of investigational drug (Visit 4a). Note: Women considered capable of becoming pregnant include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy);
•5. (If male and with female partner of childbearing potential) must use at least 1 medically acceptable form of birth control. throughout the study duration, for at least 14 days prior to the first dose of investigational drug (Visit 4a) and for 1 month after the last dose of the study drug (Visit 5) Note: Acceptable forms of birth control are true abstinence (when this is in line with the preferred and usual lifestyle of the subject) or vasectomy at least 3 months prior to the first dose of investigational drug (Visit 4a). Without a vasectomy, must use condoms with spermicidal foam/gel/film/cream/suppository.
•6. have a history of ocular allergies and a positive skin test reaction to a seasonal (grass, ragweed, tree pollen) or perennial (cat dander, dog dander, dust mites, cockroach) allergen as confirmed by an allergic skin test conducted at Visit 1 or within the past 24 months;
•7. have a calculated best-corrected visual acuity of 0.7 LogMar or better in each eye as measured using an ETDRS chart at Visit 2;
•8. have a positive bilateral CAC reaction (defined as having scores of ≥ 2 for ocular itching and ≥ 2 for conjunctival redness) within 10 minutes of instillation of the last titration of allergen at Visit 2;
•9. have a positive bilateral CAC reaction (defined as having scores of ≥ 2 for ocular itching and ≥ 2 for conjunctival redness) in at least 2 out of 3 timepoints at following the challenge at Visit 3;
+1 more criteria

Exclusion Criteria

•Subjects may not:
•1. have known contraindications or sensitivities to the use of any of the investigational product(s) or their components;
•2. have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium, or a diagnosis of dry eye);
•3. have had ocular surgical intervention within 3 months prior to enrollment (Visit 4a) and/or a history of refractive surgery within 6 months prior to enrollment (Visit 4a);
•4. have a known history of retinal detachment, diabetic retinopathy, or progressive retinal disease;
•5. have the presence of an active ocular infection (bacterial, viral or fungal), positive history of an ocular herpetic infection, or preauricular lymphadenopathy at any visit;
•6. manifest signs or symptoms of clinically active allergic conjunctivitis in either eye at the start of Visits 2, 3, or 4a (defined as a score of \>0 for itching and/or \>1 for conjunctival redness);
•7. use any of the following disallowed medications during the period indicated prior to Visit 2 and agree not to use disallowed medications throughout the study:
•7 Days
•* systemic or ocular H1 antihistamines, H1 antihistamine/mast-cell stabilizer drug combinations, H1 antihistamine-vasoconstrictor drug combinations,
+18 more criteria

Locations (4)

103

Phoenix, Arizona, United States

101

Andover, Massachusetts, United States

102

Memphis, Tennessee, United States

114

Lynchburg, Virginia, United States

Key Dates

Start Date

October 12, 2022

Primary Completion Date

July 22, 2023

Completion Date

July 22, 2023

Last Updated

February 14, 2025

Enrollment

188

ACTUAL participants

Conditions

Allergic Conjunctivitis

Interventions

Brimonidine tartrate 0.025%/ketotifen fumarate 0.035%

DRUG

Brimonidine Tartrate 0.025%

DRUG

Ketotifen Fumarate 0.035%

DRUG

Vehicle

DRUG

The Role of Vitamin D in Corneal Epithelial Barrier Function, Ocular Microbiome, Ocular Inflammation, and Visual Acuity of Children With Allergic Conjunctivitis

NCT05839938

Allergic Conjunctivitis

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ACTIVE_NOT_RECRUITING

Tyrosine Allergoid Paediatric and Adult Study

NCT05186025

Allergic Rhinitis Due to PollenAllergic Conjunctivitis+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

The Role of Vitamin D in Corneal Epithelial Barrier Function, Ocular Microbiome, Ocular Inflammation, and Visual Acuity of Children With Allergic Conjunctivitis

Tyrosine Allergoid Paediatric and Adult Study

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