A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Phase 2b Evaluation of the Onset and Duration of ADX-102 Ophthalmic Drops (0.5% and 0.1%) Compared to Vehicle of ADX-102 Ophthalmic Drops in the Conjunctival Allergen Challenge (Ora-CAC®) Model of Acute Allergic Conjunctivitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
154
ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.
ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.
Vehicle of ADX-102 Ophthalmic Drops administered twice in two weeks.
Eye Care Centers Management
Morrow, Georgia, United States
Silverstein Eye Centers
Kansas City, Missouri, United States
Apex Eye Clinical Research
Mason, Ohio, United States
Philadelphia Eye Associates
Philadelphia, Pennsylvania, United States
Ocular Itching Evaluated by the Subject at 10(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.
Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.
Time frame: Efficacy assessment period (Day 1 through Day 15), Day 15 reported.
Ocular Itching Evaluated by the Subject at 15(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.
Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.
Time frame: Efficacy assessment period (Day 1 through Day 15), Day 15 reported.
Ocular Itching Evaluated by the Subject at 20(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.
Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.
Time frame: Efficacy assessment period (Day 1 through Day 15), Day 15 reported.
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Total Eye Care
Memphis, Tennessee, United States