Overview

Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model

Status:
Completed
Trial end date:
2012-02-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the effectiveness of the modified Conjunctival Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to treatment with a proven ocular anti-inflammatory medication, Prednisolone, assessed by the following measures: - Ocular itching - Conjunctival redness
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
ORA, Inc.
Treatments:
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Ophthalmic Solutions
Pharmaceutical Solutions
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Criteria
Inclusion Criteria:

- At least 18 years of age & either sex, any race

- Willing and able to follow all instructions

- Positive history of ocular allergies

- Reproducible positive ocular allergic reaction induced by conjunctival allergen
challenge

Exclusion Criteria:

- Have planned surgery during trial period

- Female currently pregnant, planning a pregnancy or lactating

- Use of disallowed medications

- Have ocular infections, or ocular conditions that could affect study parameters

- Have moderate to severe dry eye

- Have used an investigational drug or device within 30 days of start of study

- Female that is currently pregnant, planning a pregnancy or lactating