Study Stopped
Management decision
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)
1 other identifier
interventional
N/A
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2009
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2009
CompletedFirst Posted
Study publicly available on registry
April 15, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedMarch 6, 2012
February 1, 2012
Same day
April 14, 2009
March 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary efficacy variable is mean change in tear eosinophil level at Visit 7 post-CAC from Visit 2 post-CAC.
15 days
Secondary Outcomes (1)
Mean change in relative ratio of tear eosinophil and neutrophils at Visit 7 post-CAC from Visit 2 post-CAC
15 days
Study Arms (3)
1
EXPERIMENTAL2
ACTIVE COMPARATOR3
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Have a known allergy to the study medication(s) or their components (ex., dexamethasone, benzalkonium chloride)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2009
First Posted
April 15, 2009
Study Start
May 1, 2009
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
March 6, 2012
Record last verified: 2012-02