Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle

Last updated: March 19, 2013
Sponsor: Bausch & Lomb Incorporated
Overall Status: Completed

Phase

3

Condition

Conjunctivitis, Bacterial

Allergy

Eye Disorders/infections

Treatment

N/A

Clinical Study ID

NCT01175590
631
  • Ages > 1
  • All Genders

Study Summary

The objective of this study is to evaluate the safety of Besivance (besifloxacin ophthalmic suspension, 0.6%) compared to vehicle.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects must have a clinical diagnosis of acute bacterial conjunctivitis and exhibitpurulent conjunctival discharge (crusty or sticky eyelids) and redness in at least oneeye.

  • Subjects who are willing to discontinue contact lens wear for the duration of thestudy.

  • Subjects who are able and willing to comply with all treatment and follow- up/studyprocedures.

Exclusion

Exclusion Criteria:

  • Subjects who have any uncontrolled systemic disease or debilitating disease.

  • Subjects with a known hypersensitivity or contraindications to Besivance,fluoroquinolones, or any of the ingredients in the study drugs.

  • Subjects who are expected to require disallowed concurrent systemic or oculartherapy(either eye)during or prior to study start. (ie, NSAIDs, corticosteroids, mastcell stabilizers, antihistamines, decongestants or antimicrobial therapy)

  • Subjects having ocular surgery (including laser surgery) in either eye within sixweeks prior to entry into this study.

  • Subjects with suspected viral or allergic conjunctivitis or any other diseaseconditions that could interfere with the efficacy and safety evaluations of the studymedication.

  • Subjects with suspected iritis.

  • Subjects with a history of recurrent corneal erosion syndrome, either idiopathic orsecondary to previous corneal trauma or dry eye syndrome.

  • Subjects with any active ulcerative keratitis, specifically any epithelial lossgreater than punctate keratitis.

  • Subjects who are immune compromised.

Study Design

Total Participants: 518
Study Start date:
June 01, 2010
Estimated Completion Date:
February 29, 2012

Connect with a study center

  • Bausch & Lomb, Inc.

    Rochester, New York 14609
    United States

    Site Not Available

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