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

Bausch + Lomb

Status and phase

Completed

Phase 3

Conditions

Inflammation

Cataract

Surgery

Treatments

Drug: Mapracorat

Drug: Vehicle

Study type

Interventional

Funder types

Industry

Identifiers

NCT01591655

793

Details and patient eligibility

About

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.

Enrollment

360 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.