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

Study to Assess the Efficacy and Safety of Mapracorat Ophthalmic Suspension, 3% in Subjects for the Treatment of Ocular Inflammation Following Cataract Surgery

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.

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.