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 |
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.
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