Loteprednol Etabonate Ophthalmic Ointment vs. Vehicle in the Treatment of Inflammation Following Cataract Surgery

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the clinical safety and efficacy of Loteprednol Etabonate Ophthalmic Ointment, 0.5% vs. 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:

1. Subjects who are candidate for routine, uncomplicated cataract surgery

2. Subjects who, in the Investigator's opinion, have potential postoperative pinholed Snellen visual acuity (VA) of at least 20/200 in the study eye.

Exclusion Criteria:

1. Subjects who will require concurrent ocular therapy with NSAIDs, mast cell stabilizers, antihistamines, decongestants, or immunosuppressants (e.g., Restasis), or with ocular or systemic corticosteroids

2. Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components

3. Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye

4. Subjects who have had ocular surgery (including laser surgery) in the study eye within 3 months or in the fellow eye within 2 weeks prior to the Screening Visit