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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00881673
Recruitment Status : Withdrawn (Management decision)
First Posted : April 15, 2009
Last Update Posted : March 6, 2012
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Allergic Conjunctivitis Drug: AL38583 Ophthalmic Solution Drug: Maxidex Drug: Vehicle Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Single-Center, Randomized, Double-Masked, Placebo-Controlled Evaluation of the Efficacy of AL-38583 in the Reduction of Tear Eosinophil Count Following Conjunctival Allergen Challenge (CAC)
Study Start Date : May 2009
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye Tears
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: AL38583 Ophthalmic Solution
Topical ophthalmic
Active Comparator: 2 Drug: Maxidex
Topical ophthalmic
Placebo Comparator: 3 Drug: Vehicle
AL38583 Vehicle

Primary Outcome Measures :
  1. The primary efficacy variable is mean change in tear eosinophil level at Visit 7 post-CAC from Visit 2 post-CAC. [ Time Frame: 15 days ]

Secondary Outcome Measures :
  1. Mean change in relative ratio of tear eosinophil and neutrophils at Visit 7 post-CAC from Visit 2 post-CAC [ Time Frame: 15 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Responsible Party: Alcon Research Identifier: NCT00881673     History of Changes
Other Study ID Numbers: C-09-005
First Posted: April 15, 2009    Key Record Dates
Last Update Posted: March 6, 2012
Last Verified: February 2012

Keywords provided by Alcon Research:

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases
Ophthalmic Solutions
Pharmaceutical Solutions