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)

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00881673

Enrollment

Registered

2009-04-15

Start date

2009-05-31

Completion date

2009-05-31

Last updated

2012-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Conjunctivitis

Keywords

Conjunctivitis

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).

Interventions

DRUGMaxidex

Topical ophthalmic

DRUGVehicle

AL38583 Vehicle

DRUGAL38583 Ophthalmic Solution

Topical ophthalmic

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame
The primary efficacy variable is mean change in tear eosinophil level at Visit 7 post-CAC from Visit 2 post-CAC.	15 days

Secondary

Measure	Time frame
Mean change in relative ratio of tear eosinophil and neutrophils at Visit 7 post-CAC from Visit 2 post-CAC	15 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026