NCT00881673WithdrawnPhase 2
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)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Alcon Research
- Primary Endpoint
- The primary efficacy variable is mean change in tear eosinophil level at Visit 7 post-CAC from Visit 2 post-CAC.
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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)
Arms & Interventions
1
Experimental
Intervention: AL38583 Ophthalmic Solution (Drug)
2
Active Comparator
Intervention: Maxidex (Drug)
3
Placebo Comparator
Intervention: Vehicle (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Mean change in relative ratio of tear eosinophil and neutrophils at Visit 7 post-CAC from Visit 2 post-CAC(15 days)
Investigators
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