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This study has been withdrawn prior to enrollment.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
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ 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 ]

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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00881673     History of Changes
Other Study ID Numbers: C-09-005
Study First Received: April 14, 2009
Last Updated: March 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
Conjunctivitis

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Dexamethasone
Ophthalmic Solutions
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on August 21, 2014