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This study has been withdrawn prior to enrollment.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)
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00881673
First received: April 14, 2009
Last updated: March 3, 2012
Last verified: February 2012

April 14, 2009
March 3, 2012
May 2009
May 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00881673 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
To Evaluate the Efficacy of AL-38583 in the Reduction of Tear Eosinophil Count Following Conjunctival Allergen Challenge
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)

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Allergic Conjunctivitis
  • Drug: AL38583 Ophthalmic Solution
    Topical ophthalmic
  • Drug: Maxidex
    Topical ophthalmic
  • Drug: Vehicle
    AL38583 Vehicle
  • Experimental: 1
    Intervention: Drug: AL38583 Ophthalmic Solution
  • Active Comparator: 2
    Intervention: Drug: Maxidex
  • Placebo Comparator: 3
    Intervention: Drug: Vehicle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
May 2009
May 2009   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00881673
C-09-005
Yes
Alcon Research
Alcon Research
Not Provided
Not Provided
Alcon Research
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP