Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery

Inclusion criteria

• Subjects at least 18 years of age
• Subjects who have the ability to understand and sign an informed consent form and provide Health Insurance Portability and Accountability Act (HIPAA) authorization.
• Subjects who are candidate for routine, uncomplicated cataract surgery.
• Subjects who are not of childbearing potential or subjects who have a negative urine pregnancy test result at screening.
• Subjects must be willing and able to comply with all treatment and follow- up procedures.

Exclusion criteria

• Subjects who have known hypersensitivity or contraindication to the study drug or its components.
• Subjects who have a history or presence of chronic generalized systemic disease that the investigator feels might increase the risk to the subject or compound the result of the study.
• Subjects who have a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up.
• Subjects with elevated intraocular pressure (>/= 21 mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye.
• Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye.
• Subjects who have had ocular surgery in the study eye within 3 months or in the fellow eye within 2 weeks prior to the screening visit.
• Women who are pregnant or breast feeding.
• Subjects who have participated in an investigational drug or device study within the last 30 days.
• Subjects previously randomized in this study.