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

Bausch + Lomb

Status and phase

Terminated

Phase 3

Conditions

Inflammation

Cataract

Pain

Treatments

Drug: Vehicle

Drug: Mapracorat

Study type

Interventional

Funder types

Industry

Identifiers

NCT01298752

664

Details and patient eligibility

About

The objective of this 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.

Enrollment

177 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects who are candidates for routine, uncomplicated cataract surgery.
Subjects must be willing to wait to undergo cataract surgery on the fellow eye until after the study has been completed.

Exclusion criteria

Subjects who are expected to require treatment with any systemic or ocular (either eye) drugs specified in the protocol during the 18 days following cataract surgery or any systemic or ocular corticosteroids within 14 days prior to cataract surgery.
Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components.
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.