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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-09-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Allergic Conjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Maxidex

Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\]

Group Type EXPERIMENTAL

Dexamethasone 0.1% ophthalmic suspension

Intervention Type DRUG

Maxidex

Patanol

Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\]

Group Type EXPERIMENTAL

Olopatadine hydrochloride 0.1% ophthalmic solution

Intervention Type DRUG

Patanol

Tears Naturale II

Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\]

Group Type PLACEBO_COMPARATOR

Inactive ingredients, used as placebo

Intervention Type OTHER

Tears Naturale II

Interventions

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Dexamethasone 0.1% ophthalmic suspension

Maxidex

Intervention Type DRUG

Olopatadine hydrochloride 0.1% ophthalmic solution

Patanol

Intervention Type DRUG

Inactive ingredients, used as placebo

Tears Naturale II

Intervention Type OTHER

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No