Evaluation of Prednisolone in a Modified Conjunctival Allergen Challenge Model

• Status: Completed
• Trial end date: 2012-12-01
• 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:

Chronic Allergic Inflammation assessed using confocal microscopy 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