Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation and Pain Following … (NCT01591161) | Clinical Trial Compass
CompletedPhase 3
Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
United States369 participantsStarted 2012-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells