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



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:11/30/-0001
Start Date:July 2012
End Date:August 2013
Contact:Colleen McCallum, MBA
Email:Colleen.McCallum@bausch.com
Phone:(585) 338-6048

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


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.


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.
We found this trial at
1
site
Rochester, New York 14609
?
mi
from
Rochester, NY
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