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

Last updated: August 18, 2020
Sponsor: Bausch & Lomb Incorporated
Overall Status: Terminated

Phase

3

Condition

Eye Disorders/infections

Pain

Inflammation

Treatment

N/A

Clinical Study ID

NCT01298752
664
  • Ages > 18
  • All Genders

Study Summary

The objective of this study is to compare the safety and efficacy of Mapracorat Ophthalmic Suspension, 3% to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects who are candidates for routine, uncomplicated cataract surgery.

  • Subjects must be willing to wait to undergo cataract surgery on the fellow eye untilafter the study has been completed.

Exclusion

Exclusion Criteria:

  • Subjects who are expected to require treatment with any systemic or ocular (eithereye) drugs specified in the protocol during the 18 days following cataract surgery orany systemic or ocular corticosteroids within 14 days prior to cataract surgery.

  • Subjects who have known hypersensitivity or contraindication to the study drug(s) ortheir components.

  • Subjects who have a severe/serious ocular condition or history/presence of chronicgeneralized systemic disease that the Investigator feels might increase the risk tothe subject or confound the result(s) of the study.

Study Design

Total Participants: 177
Study Start date:
February 01, 2011
Estimated Completion Date:
November 30, 2011

Connect with a study center

  • Bausch & Lomb Incorporated

    Rochester, New York 14609
    United States

    Site Not Available

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