Overview

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

Status:
Completed
Trial end date:
2013-07-01
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.
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.