Clinical Trial: Assessing the Efficacy of Maxidex® and Patanol® for the Treatment of Allergic Conjunctivitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-Masked, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of Maxidex® (0.1% Dexamethasone) Ophthalmic Suspension and Patanol® (0.1% Olopatadine Hydrochlori

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 Summary: 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.
Sponsor: Alcon Research

Current Primary Outcome:

• Mean Change From Baseline in Staff-Assessed Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)], Maxidex and Placebo [ Time Frame: Baseline (Visit 3, pre-treatment); Visit 6 (Day 9 of treatment) ]
  Ocular redness ratings were collected for nasal and temporal areas of each eye and scored on a scale from 0 (none) to 4 (extremely severe), 0.5 unit steps permitted. The AUC computation was based on peak redness score (maximum of four areas of redness) at each time point (pre-treatment, 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3 hours in the EEC and 3.5, 4, 5, 6, 7, 8, 9, 10 hours in the Clinic). The patient was dosed AM 30 minutes prior to entering the EEC (Visit 6). This outcome measure evaluates a late-phase effect, for which Maxidex vs. Placebo is the meaningful comparison.
• Mean Change From Baseline Patient-Assessed Ocular Itching, Area Under the Curve From Time Zero to Hour 3 [AUC (0-3)], Patanol and Placebo [ Time Frame: Baseline (Visit 2, pre-treatment), Visit 5 (Day 8 of treatment) ]
  Ocular itching was scored a scale from 0 (none) to 4 (incapacitating itch with irresistible urge to rub) in 0.5 unit steps. The AUC computation was based on the score at each time point (pre-treatment, 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, and 3 hours in the EEC). The patient was dosed AM 30 minutes prior to entering the EEC (Visit 5). This outcome measure evaluates an early-phase effect, for which Patanol vs. Placebo is the meaningful comparison.

Original Primary Outcome:

• Change in ocular redness [ Time Frame: Baseline to Day 17 ]
• Change in ocular itching [ Time Frame: Baseline to Day 16 ]

Current Secondary Outcome:

Original Secondary Outcome:

• Change in ocular redness [ Time Frame: Baseline to Day 16 ]
• Change in ocular itching [ Time Frame: Baseline to Day 17 ]

Dates:
Date Received: May 4, 2010
Date Started: March 2010
Date Completion:
Last Updated: February 27, 2014
Last Verified: March 2013