To evaluate the efficacy of Combo compared to its individual components and compared to vehicle in a population of subjects with seasonal allergic conjunctivitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
229
Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution
Ketotifen fumarate ophthalmic solution 0.035%
Brimonidine tartrate ophthalmic solution 0.025%
104 Butchertown Clinical Trials
Louisville, Kentucky, United States
101 Andover Eye Associates
Andover, Massachusetts, United States
105 - Advancing Vision Research
Goodlettsville, Tennessee, United States
102 Total Eye Care, PA
Memphis, Tennessee, United States
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.
Time frame: 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.
Time frame: Assessed up to 480 minutes post-instillation of assigned IP
Tearing Measured by Watery Eyes Scale
Tearing 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, NOT allowing half unit increments), with 4 being the worse outcome.
Time frame: up to 480 minutes post-instillation of assigned IP
Lid Swelling Measured by Eyelid Swelling Scale
Lid swelling 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 (0-3 scale, NOT allowing half unit increments), with 3 being the worst outcome
Time frame: up to 480 minutes post-instillation of assigned IP
Chemosis Evaluated
Chemosis 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.
Time frame: up to 480 minutes post-instillation of assigned IP
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Experimental: Vehicle ophthalmic solution
108 Emerson Clinical Research Institute Inc.
Falls Church, Virginia, United States
107 Virginia Eye Institute
Richmond, Virginia, United States