Evaluation of the Combination Drug Product Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution Compared to Its Components and Vehicle in an Allergen BioCube® in Subjects With Seasonal Allergic Conjunctivitis
Sponsor study identifier
interventional
229
1 country
6
Study Start
November 18, 2022
Actual (reported)Primary Completion
August 9, 2023
Actual (reported)Study Completion
August 9, 2023
Actual (reported)To evaluate the efficacy of Combo compared to its individual components and compared to vehicle in a population of subjects with seasonal allergic conjunctivitis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 9, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 6, 2022
Actual (reported)October 24, 2022
Actual (reported)November 18, 2022
Actual (reported)August 9, 2023
Actual (reported)August 9, 2023
Actual (reported)July 1, 2025
Actual (reported)Ocular Itching Symptom Score
Ocular itching score evaluated by the subject at 10(±1), 30(±1), 60(±5), 360(±5), 420(±5), and 480(±5) minutes post-instillation of assigned IP at Visit 2 (0-4 scale, allowing half unit increments), with 4 is the worse outcome.
Assessed up to 480 minutes post-instillation of assigned IP
Ocular Redness Measured by Ocular Itching Scale
Ocular redness evaluated by the Investigator using slit lamp at 10(±1), 30(±1), 60(±5), 360(±5), 420(±5), and 480(±5) minutes post-instillation of assigned IP at Visit 2 (0-4 scale, allowing half unit increments), with 4 being the worse outcome.
Assessed up to 480 minutes post-instillation of assigned IP
Tearing Measured by Watery Eyes Scale
up to 480 minutes post-instillation of assigned IP
Lid Swelling Measured by Eyelid Swelling Scale
up to 480 minutes post-instillation of assigned IP
Chemosis Evaluated
up to 480 minutes post-instillation of assigned IP
Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution
Ketotifen fumarate ophthalmic solution 0.035%
Brimonidine tartrate ophthalmic solution 0.025%
Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution
Ketotifen fumarate ophthalmic solution 0.035%
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record104 Butchertown Clinical Trials
Louisville, Kentucky, 40206, United States
101 Andover Eye Associates
Andover, Massachusetts, 01810, United States
105 - Advancing Vision Research
Goodlettsville, Tennessee, 37072, United States
102 Total Eye Care, PA
Memphis, Tennessee, 38119, United States
108 Emerson Clinical Research Institute Inc.
Falls Church, Virginia, 22046, United States
107 Virginia Eye Institute
Richmond, Virginia, 23230, United States
229 participants (actual enrollment reported by the registry).
First Submitted
October 6, 2022
First Posted
October 24, 2022
Study Start
November 18, 2022
Actual (reported)Vehicle ophthalmic solution
Brimonidine tartrate ophthalmic solution 0.025%
Experimental: Vehicle ophthalmic solution
Contact the study team to confirm eligibility.
Primary Completion
August 9, 2023
Actual (reported)Study Completion
August 9, 2023
Actual (reported)Last Updated
July 1, 2025
Results First Posted
July 1, 2025
Record last verified: 2025-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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