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

Phase 4

Completed

• Conditions: Allergic Conjunctivitis
• Interventions: Drug: Dexamethasone 0.1% ophthalmic suspension; Drug: Olopatadine hydrochloride 0.1% ophthalmic solution; Other: Inactive ingredients, used as placebo

• Registration Number: NCT01119287
• Lead Sponsor: Alcon Research

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-05-04
• Study First Submitted QC: 2010-05-06
• Study First Posted: 2010-05-07
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Results First Submitted: 2013-01-28
• Status Verified: 2013-03
• Results First Submitted QC: 2013-03-04
• Results First Posted: 2013-03-06
• Last Update Submitted: 2014-02-27
• Last Update Posted: 2014-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maxidex	Dexamethasone 0.1% ophthalmic suspension	Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\]
Patanol	Olopatadine hydrochloride 0.1% ophthalmic solution	Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\]
Tears Naturale II	Inactive ingredients, used as placebo	Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\]

Primary Outcome Measures

Name	Time	Method
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	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	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.

Trial Locations

Locations (1)

Contact Alcon Call Center For Trial Locations; 🇺🇸 Fort Worth, Texas, United States