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

Allergic Conjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01119287
• Other study ID #: C-10-002
• Status: Completed
• Phase: Phase 4
• First received: May 4, 2010
• Last updated: February 27, 2014
• Start date: March 2010
• Est. completion date: September 2010

Study information

• Verified date: March 2013
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• Dexamethasone 0.1% ophthalmic suspension
Maxidex
• Olopatadine hydrochloride 0.1% ophthalmic solution
Patanol

Other:
• Inactive ingredients, used as placebo
Tears Naturale II

Locations

Country	Name	City	State
United States	Contact Alcon Call Center For Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline (Visit 3, pre-treatment); Visit 6 (Day 9 of treatment)	No
Primary	Mean Change From Baseline Patient-Assessed Ocular Itching, Area Under the Curve From Time Zero to Hour 3 [AUC (0-3)], Patanol and Placebo	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.	Baseline (Visit 2, pre-treatment), Visit 5 (Day 8 of treatment)	No