Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this clinical study is to compare the safety and efficacy of mapracorat ophthalmic suspension, 3% with its vehicle for the treatment of postoperative inflammation and pain following cataract surgery. Participants from the United States and Canada will be recruited for this study.

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

Details

• Lead Sponsor: Bausch & Lomb Incorporated

Criteria

Inclusion Criteria:

• Subjects who are candidates for routine, uncomplicated cataract surgery.

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

• Subjects who have ≥ Grade 2 (6 - 15 cells) AC cells in the study eye following cataract surgery (postoperative day 1).

Exclusion Criteria:

• Subjects who have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.

• Any intraocular inflammation in either eye (cells or flare score greater than Grade 0 at slit lamp examination) or ocular pain greater than Grade 1 in the study eye at the Screening Visit.

• Presence of active external ocular disease: infection or inflammation of the study eye.

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

• Subjects who currently require or are expected to require treatment with any medication listed as a disallowed medication per the Disallowed Therapy section of the protocol.