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

Single Center, Randomized, Double-Masked Evaluation of the Efficacy of PredAcetate 1% Ophthalmic Suspension Compared to Pred Acetate 0.12% Ophthalmic Suspension, Lot Etab 0.2% Ophthalmic Suspension, and Placebo in a Modified CAC Model

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.

Structure:

Prospective, single center, randomized, double-masked, parallel treatment comparison study. Subjects will be randomized to one of the following treatment arms to be dosed bilaterally twice daily (BID) for the first dosing period and four times daily (QID) for the second dosing period:

1. Prednisolone Acetate 1% ophthalmic suspension
2. Prednisolone Acetate 0.12% ophthalmic suspension
3. Loteprednol Etabonate 0.2% ophthalmic suspension
4. Tears Naturale® II

Duration:

Approximately four (4) weeks

Controls:

Artificial Tears (Tears Naturale® II)

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