Skip to main content
Clinical Trials/NCT00881673
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)

Alcon Research0 sitesStarted: May 2009Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Withdrawn
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

Sponsor Class
Industry
Responsible Party
Sponsor

Similar Trials

To Evaluate the Efficacy of AL-38583 in... | Clinical Trial