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

Completed · Phase 4 · Has a placebo group

Conditions studied: Allergic Conjunctivitis

In brief

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.

Key facts

Study ID

NCT00689078

Run by

ORA, Inc.

People needed

36

Starts

2008-05-01

Expected to finish

2008-06-01

Last updated by the study team

2020-09-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ophthalmic Research Associates — Andover, Massachusetts, United States

Full record on ClinicalTrials.gov

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