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

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

Phase

3

Condition

Inflammation

Eye Disease

Eye Disorders/infections

Treatment

N/A

Clinical Study ID

NCT01230125
663
  • Ages > 18
  • All Genders

Study Summary

The objective of this clinical 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:

  • Participants who are candidates for routine, uncomplicated cataract surgery

  • Participants who, in the Investigator's opinion, have potential postoperative pinholeSnellen visual acuity (VA) of at least 20/200 in the study eye.

  • Participants must be willing to wait to undergo cataract surgery on the fellow eyeuntil after the study has been completed.

Exclusion

Exclusion Criteria:

  • Participants who are expected to require concurrent ocular therapy (either eye) withnonsteroidal anti-inflammatory drugs (NSAIDs), mast cell stabilizers, antihistamines,or decongestants.

  • Participants who are expected to require treatment with any systemic or ocular (eithereye) corticosteroids or glucocorticoids.

  • Participants who are expected to require concurrent ocular therapy withimmunosuppressants (eg, Restasis).

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

  • Participants participating in any drug or device clinical investigation within 30 daysprior to entry into this study and/or during the period of study participation.

Study Design

Total Participants: 311
Study Start date:
November 01, 2010
Estimated Completion Date:
August 31, 2011

Connect with a study center

  • Bausch & Lomb, Incorporated

    Rochester, New York 14609
    United States

    Site Not Available

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