To Evaluate the Efficacy of AL-38583 in the Reduction of Tear Eosinophil Count Following Conjunctival Allergen Challenge

Alcon

Status and phase: Withdrawn; Phase 2

Conditions: Allergic Conjunctivitis

Treatments: Drug: AL38583 Ophthalmic Solution; Drug: Vehicle; Drug: Maxidex

Study type: Interventional

Funder types: Industry

Identifiers

NCT00881673

C-09-005

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 3 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: AL38583 Ophthalmic Solution

2

Active Comparator group

Treatment:

Drug: Maxidex

3

Placebo Comparator group

Treatment:

Drug: Vehicle