The INVIGORATE 2 Trial: A single-center, 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
131
Reproxalap Ophthalmic Solution (0.25%) dosed twice.
Vehicle Ophthalmic Solution dosed twice.
Cliantha Research
Mississauga, Ontario, Canada
Ocular itching evaluated by the Subject.
The method of assessment for the primary outcome is a 9-point ocular itch scale (0 none - 4 severe).
Time frame: During EEC allergen exposure.
Conjunctival redness evaluated by the Subject.
The method of assessment for the key secondary outcome is a 9-point ocular redness scale (0 none - 4 extremely severe).
Time frame: During EEC allergen exposure.
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