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

This study has been withdrawn prior to enrollment.
(Management decision)
Information provided by (Responsible Party):
Alcon Research Identifier:
First received: April 14, 2009
Last updated: March 3, 2012
Last verified: February 2012
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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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)

Resource links provided by NLM:

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 ]

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 ]

Enrollment: 0
Study Start Date: May 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AL38583 Ophthalmic Solution
Topical ophthalmic
Active Comparator: 2 Drug: Maxidex
Topical ophthalmic
Placebo Comparator: 3 Drug: Vehicle
AL38583 Vehicle


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)
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

Responsible Party: Alcon Research Identifier: NCT00881673     History of Changes
Other Study ID Numbers: C-09-005
Study First Received: April 14, 2009
Last Updated: March 3, 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 processed this record on May 22, 2017