To evaluate the efficacy and safety of PR013 topical ophthalmic drops (0.045% and 0.06%) compared to vehicle for the treatment of the signs and symptoms of allergic conjunctivitis using a modified Conjunctival Allergen Challenge Model (Ora-CAC®).
A Multi-Center, Double-Masked, Randomized, Phase 2 Evaluation of the Effectiveness of PR013 Topical Ophthalmic Drops (0.045% and 0.06%) Compared to Vehicle of PR013 Topical Ophthalmic Drops for the Treatment of Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model (Ora-CAC®)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
96
PR013 topical Ophthalmic Drops (0.045%)
PR013 topical Ophthalmic Drops (0.06%)
Vehicle
Principal Investigator
Philadelphia, Pennsylvania, United States
Ocular itching evaluated by the subject
The method of assessment for this outcome is the Ora Calibra(TM) Conjunctival Allergen Challenge Ocular Itching Scale
Time frame: [Time Frame: Efficacy assessment period (Day 7 through Day 8)]
Conjunctival redness evaluated by the Investigator
Ora Calibra(TM) Ocular Hyperemia Scale
Time frame: [Time Frame: Efficacy assessment period (Day 7 through Day 8)]
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