Mapracorat Ophthalmic Suspension for the Treatment of Ocular Inflammation Following Cataract Surgery

• Status: Completed
• Trial end date: 2011-08-01
• 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% to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.

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

Details

• Lead Sponsor: Bausch & Lomb Incorporated

Criteria

Inclusion Criteria:

• Participants who are candidates for routine, uncomplicated cataract surgery

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

• Participants must be willing to wait to undergo cataract surgery on the fellow eye until after the study has been completed.

Exclusion Criteria:

• Participants who are expected to require concurrent ocular therapy (either eye) with nonsteroidal anti-inflammatory drugs (NSAIDs), mast cell stabilizers, antihistamines, or decongestants.

• Participants who are expected to require treatment with any systemic or ocular (either eye) corticosteroids or glucocorticoids.

• Participants who are expected to require concurrent ocular therapy with immunosuppressants (eg, Restasis).

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

• Participants participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.