Clinical trial NCT01119287: Assessing the Efficacy of Maxidex® and Patanol® for the Treatment of Allergic Conjunctivitis
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 Hydrochloride) Ophthalmic Solution for the Treatment of Allergic Conjunctivitis in an Environmental Exposure Chamber (EEC) Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Conjunctivitis
Keywords: Conjunctivitis
ocular allergy
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-05-07
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* At least 1 year history of allergic conjunctivitis.
* Ability to self administer ophthalmic drops.
* Ability to avoid use of disallowed medications during the entire study period and specified period prior to visit 1.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Presence of any ocular infection.
* Confirmed diagnosis of dry eye.
* Presence of glaucoma or ocular hypertension.
* Moderate to severe asthma.
* Any severe, unstable, or uncontrolled systemic disease.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: 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
timeFrame: Baseline (Visit 3, pre-treatment); Visit 6 (Day 9 of treatment)
measure: Mean Change From Baseline Patient-Assessed Ocular Itching, Area Under the Curve From Time Zero to Hour 3 [AUC (0-3)], Patanol and Placebo
timeFrame: Baseline (Visit 2, pre-treatment), Visit 5 (Day 8 of treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center For Trial Locations
state: Texas
Study officials:
References: