Conditions: Allergic Conjunctivitis
Keywords: Allergic Conjunctivitis Ocular Allergy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 397
Healthy volunteers: no

Brief summary:
The purpose of this study was to assess the safety and efficacy of AL-4943A ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis using the Conjunctival Allergen Challenge (CAC) model.

Detailed description:
This study consisted of 5 Visits. Eligible patients underwent allergy testing using the Conjunctival Allergen Challenge (CAC) model, which reproduces the signs and symptoms of Seasonal Allergic Conjunctivitis by replicating the natural disease process. Patients demonstrating a positive reaction to the CAC at Visit 1 (screening) and Visit 2 (confirmatory) were randomized to treatment at Visit 3 (Day 0). The test article was instilled at Visit 3, with treatment efficacy CAC performed at 24 hours duration of action. The test article was instilled again at Visit 4 (Day 14), with treatment efficacy CAC performed at 16 hours duration of action. The test article was instilled a final time at Visit 5 (Day 21), with treatment efficacy performed at onset of action.

Arms:
arm 1: AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days arm 2: AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days arm 3: Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days

Interventions: intervention 1: AL-4943A ophthalmic solution intervention 2: AL-4943A vehicle intervention 3: Olopatadine hydrochloride ophthalmic solution, 0.2%
Intervention descriptions: intervention 1: None intervention 2: Inactive ingredients used as placebo intervention 3: None

Protocol document: