Evaluation of the clinical safety and efficacy of loteprednol etabonate in an ophthalmic
base, when compared to vehicle for the treatment of inflammation following cataract surgery.
- 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
- Subjects who have known hypersensitivity or contraindication to the study drug or its
- 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
- 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
- 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.