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

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy of prednisolone acetate 1% ophthalmic suspension as compared to prednisolone acetate 0.12% ophthalmic suspension, loteprednol etabonate 0.2% ophthalmic suspension, and placebo (Tears Naturale® II) in the prevention of the signs and symptoms of allergic conjunctivitis. Comparisons will be made following 1 week of twice daily (BID) dosing and 1 week of four times daily (QID) dosing.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ORA, Inc.
• Treatments: Loteprednol Etabonate; Lubricant Eye Drops; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; 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