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Completed

NCT Number: NCT01119287

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

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).

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Key information

Conditions

Allergic Conjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Contact Alcon Call Center For Trial Locations

Fort Worth, Texas, 76134, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexamethasone 0.1% ophthalmic suspension

Drug

Maxidex

Olopatadine hydrochloride 0.1% ophthalmic solution

Drug

Patanol

Inactive ingredients, used as placebo

Other

Tears Naturale II

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 7, 2010
Registry last updated
Feb 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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