Conditions: Allergic Conjunctivitis
Keywords: Conjunctivitis ocular allergy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 180
Healthy volunteers: no

Brief summary:
The purpose of this study was to evaluate the efficacy of Maxidex and Patanol compared to placebo in patients with allergic conjunctivitis when exposed to controlled allergen levels in an Environmental Exposure Chamber (EEC).

Detailed description:
This study consisted of 6 visits. Visit 1 was the Medical Screening Visit (skin prick test). Visit 2 and Visit 3 consisted of 2 consecutive EEC Visits (3 hours in the EEC followed by 7 hours in the Clinic, 10 hours total, each visit) followed by 7 days of wash-out. Visit 2 and Visit 3 occurred prior to dispense and the measures obtained during these visits were used as baseline. At Visit 4 patients were randomized and dispensed the assigned study medication for 7 days of at-home dosing. Visit 5 (Day 8 of treatment) and Visit 6 (Day 9 of treatment) consisted of 2 additional consecutive EEC Visits (3 hours in the EEC followed by 7 hours in the clinic, 10 hours total, each visit). During each EEC visit, patients were exposed to either ragweed or cat allergen, depending on their skin prick test results. Of the 180 participants enrolled, 170 received at least one dose of study treatment and were randomized to one of the three study treatments.

Arms:
arm 1: Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\] arm 2: Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\] arm 3: Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\]

Interventions: intervention 1: Dexamethasone 0.1% ophthalmic suspension intervention 2: Olopatadine hydrochloride 0.1% ophthalmic solution intervention 3: Inactive ingredients, used as placebo
Intervention descriptions: intervention 1: Maxidex intervention 2: Patanol intervention 3: Tears Naturale II

Protocol document: