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

NCT05579730 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 909
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (2)

• Ocular Itching

  Ocular itching score (measured on a 0-4 unit scale, allowing half-unit increments; average score of the subject's two eyes) assessed by the subjects at 3 (±1), 5 (±1), and 7 (±1) minutes post-CAC.

  Assessed at Visit 4b on day 1 (duration of action CAC at 8 hours post-instillation of study medication) and Visit 5 on day 15 (onset of action CAC at 15 minutes post-instillation of study medication).

• Conjunctival Redness

  Conjunctival redness score (measured on a 0-4unit scale, allowing half-unit increments; average score of the subject's two eyes) assessed by investigator at 7 (±1), 15 (±1), and 20 (±1) minutes post-CAC.

  Assessed at Visit 4b on day 1 (duration of action CAC at 8 hours post-instillation of study medication) and Visit 5 on day 15 (onset of action CAC at 15 minutes post-instillation of study medication).

Study Arms (4)

Combination

EXPERIMENTAL

Brimonidine tartrate 0.025%/ketotifen fumarate 0.035% combination ophthalmic solution

Drug: Brimonidine tartrate 0.025%/ketotifen fumarate 0.035%

Ketotifen fumarate

ACTIVE COMPARATOR

ketotifen fumarate 0.035% ophthalmic solution

Drug: Ketotifen Fumarate 0.035%

Brimonidine tartrate

ACTIVE COMPARATOR

brimonidine tartrate 0.025% ophthalmic solution

Drug: Brimonidine Tartrate 0.025%

Vehicle

PLACEBO COMPARATOR

vehicle ophthalmic solution

Drug: Vehicle

Interventions

Brimonidine tartrate 0.025%/ketotifen fumarate 0.035% DRUG

combination ophthalmic solution

Combination

Brimonidine Tartrate 0.025% DRUG

ophthalmic Solution

Brimonidine tartrate

Ketotifen Fumarate 0.035% DRUG

ophthalmic Solution

Ketotifen fumarate

Vehicle DRUG

ophthalmic Solution

Vehicle

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must:
• be at least 10 years of age of either sex and any race;
• 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;
• be willing and able to follow all instructions and attend all study visits;
• (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);
• (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.
• 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;
• 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;
• 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;
• 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;
• be able and willing to discontinue wearing contact lenses for at least 72 hours prior to Visit 2 and during the study trial period.

You may not qualify if:

• Subjects may not:
• have known contraindications or sensitivities to the use of any of the investigational product(s) or their components;
• 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);
• 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);
• have a known history of retinal detachment, diabetic retinopathy, or progressive retinal disease;
• 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;
• 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);
• 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:
• Days
• systemic or ocular H1 antihistamines, H1 antihistamine/mast-cell stabilizer drug combinations, H1 antihistamine-vasoconstrictor drug combinations,
• decongestants,
• immunotherapeutic agents,
• monoamine oxidase inhibitors,
• artificial tears,
• eye whiteners (eg, vasoconstrictors),

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (4)

103

Phoenix, Arizona, 85032, United States

Location

101

Andover, Massachusetts, 01810, United States

Location

102

Memphis, Tennessee, 38119, United States

Location

114

Lynchburg, Virginia, 24502, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

Brimonidine Tartrate

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Daniel Donatello
• Organization: Bausch & Lomb

Daniel.Donatello@bausch.com

585-338-5306

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: October 14, 2022
• Study Start: October 12, 2022
• Primary Completion: July 22, 2023
• Study Completion: July 22, 2023
• Last Updated: February 14, 2025
• Results First Posted: February 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)