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

This study is not yet open for participant recruitment.

Verified by Alcon Research, April 2009

First Received: April 14, 2009 No Changes Posted

Sponsored by:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00881673

Purpose

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	Intervention	Phase
Allergic Conjunctivitis	Drug: AL38583 Ophthalmic Solution Drug: Maxidex Drug: Vehicle	Phase II

MedlinePlus related topics: Pinkeye

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by Alcon Research:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Mean change in relative ratio of tear eosinophil and neutrophils at Visit 7 post-CAC from Visit 2 post-CAC [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: AL38583 Ophthalmic Solution Topical ophthalmic
2: Active Comparator	Drug: Maxidex Topical ophthalmic
3: Placebo Comparator	Drug: Vehicle AL38583 Vehicle

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881673

Contacts

Contact: Alcon Call Center

1-888-451-3937

Locations

United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134

Sponsors and Collaborators

Alcon Research

More Information

No publications provided

Responsible Party:	Alcon Research, Ltd. ( Michael J. Brubaker, Ph.D/VP External Disease )
Study ID Numbers:	C-09-005
Study First Received:	April 14, 2009
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00881673 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alcon Research:

Conjunctivitis

Study placed in the following topic categories:

Dexamethasone
Lacerations
Hypersensitivity
Conjunctivitis, Allergic
Eye Diseases

Hypersensitivity, Immediate
Conjunctivitis
Dexamethasone acetate
Conjunctival Diseases

Additional relevant MeSH terms:

Hypersensitivity
Immune System Diseases
Conjunctivitis, Allergic
Eye Diseases

Hypersensitivity, Immediate
Conjunctivitis
Conjunctival Diseases

ClinicalTrials.gov processed this record on May 07, 2009