To Evaluate the Efficacy of AL-38583 in the Reduction of Tear Eosinophil Count Following Conjunctival Allergen Challenge

NCT ID: NCT00881673

Last Updated: 2012-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-05-31

Brief Summary

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The purpose of the study is to determine whether Al38583 Ophthalmic Solution is safe and effective in reducing tear eosinophil levels at 5-8 hours after Conjunctival Allergen Challenge (CAC).

Detailed Description

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Conditions

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Allergic Conjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

AL38583 Ophthalmic Solution

Intervention Type DRUG

Topical ophthalmic

2

Group Type ACTIVE_COMPARATOR

Maxidex

Intervention Type DRUG

Topical ophthalmic

3

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

AL38583 Vehicle

Interventions

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AL38583 Ophthalmic Solution

Topical ophthalmic

Intervention Type DRUG

Maxidex

Topical ophthalmic

Intervention Type DRUG

Vehicle

AL38583 Vehicle

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have a positive bilateral CAC reaction (\>2 itching and \> conjunctival redness) to cat hair, cat dander, dust mites, cockroaches and/or dog dander within 10 minutes of instillation of the last titration of allergen at Visit 1

Exclusion Criteria

* Have a known allergy to the study medication(s) or their components (ex., dexamethasone, benzalkonium chloride)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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C-09-005

Identifier Type: -

Identifier Source: org_study_id

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