Overview

AL-38583 Ophthalmic Solution for Allergic Conjunctivitis Associated Inflammation

Status:
Completed
Trial end date:
2010-04-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to assess the safety and efficacy of AL-38583 in the treatment of the signs of inflammation associated with allergic conjunctivitis.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Alcon Research
Collaborator:
Ophthalmic Research Associates, Inc.
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Ophthalmic Solutions
Pharmaceutical Solutions
Criteria
Inclusion Criteria:

- Presence of signs and symptoms of ocular inflammation in both eyes.

- Have a positive CAC response at Visit 1.

- Able to avoid the use of disallowed medications as well as contact lens wear for the
specified period prior to Visit 1, and for the duration of the study.

- Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

- Have known history or presence of persistent dry eye syndrome.

- Presence of any ophthalmic abnormality that may affect the study outcomes.

- Have a history of moderate to severe allergic asthma reaction to mountain cedar or the
perennial allergens used in the study.

- Other protocol-defined exclusion criteria may apply.