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

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch & Lomb Incorporated
• Treatments: Loteprednol Etabonate

Criteria

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.