A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte

A Multi-Center, Randomized, Double Masked, Bioequivalence Study of Tobramycin and Prednisolone Acetate (0.3/1.0%, ISTA) Ophthalmic Suspension Compared to PredForte (1.0% Prednisolone Acetate, Allergan) Ophthalmic Suspension

The purpose of this study is to demonstrate the bioequivalence of the combination test agent, prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension compared to PredForte (prednisolone acetate 1.0%) ophthalmic suspension. Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate.

Inclusion Criteria:

• Bilateral cataract surgery
• Avoid disallowed medications throughout study

Exclusion Criteria:

• Contraindications to the use of the test agents
• Known allergy or sensitivity to the test agents or components
• History of steroid response following topical administration of corticosteroids in the eye
• Wore contact lenses 48 hours prior to Visit 1
• An intraocular pressure that is greater than 22 mmHg or less than 5 mmHg in either eye
• Any significant illness that could be expected to interfere with study
• Used ophthalmic, topical or systemic corticosteroids or an immunomodulator for 7 days prior to surgery