The INVIGORATE Trial: A Randomized, Double-masked, Crossover Design, Phase 3 Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis.
The INVIGORATE Trial: A Randomized, Double-masked, Crossover Design, Vehicle-controlled Phase 3 Clinical Trial to Assess the Efficacy and Safety of Reproxalap Ophthalmic Solution (0.25%) Compared to Vehicle in Subjects With Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber (EEC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
95
Reproxalap Ophthalmic Solution (0.25%) dosed in the Environmental Exposure Chamber.
Vehicle Ophthalmic Solution dosed in the Environmental Exposure Chamber.
Cliantha Research
Mississauga, Ontario, Canada
Subject-Reported Ocular Itching Score Assessed Over 110 to 210 Minutes in the Allergy Chamber
Change from baseline comparison of reproxalap to vehicle for ocular itching on a 0 to 4 scale ( 0 = none, 4 = severe). The treatment comparison was performed using a mixed model repeated measures approach for a crossover trial with two treatment periods. The model included time point, treatment, treatment period, treatment sequence, and interaction between time point and treatment as fixed effects, and subject nested within treatment sequence as a repeated measure.
Time frame: The efficacy assessment period was 110 to 210 minutes in the allergy chamber; baseline was pre-Dose #1 for each treatment period.
Conjunctival Redness Score Assessed Over 12 to 212 Minutes in the Allergy Chamber
Change from baseline comparison of reproxalap to vehicle for conjunctival redness on a 0 to 4 scale ( 0 = none, 4 = extremely severe). The treatment comparison was performed using a mixed model repeated measures approach for a crossover trial with two treatment periods. The model included time point, treatment, treatment period, treatment sequence, and interaction between time point and treatment as fixed effects, and subject nested within treatment sequence as a repeated measure.
Time frame: The efficacy assessment period was 12 to 212 minutes in the allergy chamber; baseline was pre-Dose #1 for each treatment period.
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