Surveillance of Ocular Surface Flora (SURFACE)

Topical fluoroquinolones (FQs) have achieved widespread use in ophthalmology for both the treatment and prophylaxis of ocular infections. The present study is set to determine the bacteria present on the ocular surface in patients at the time of cataract surgery and to assess the rate of resistance of ocular isolates to commonly used topical antibiotics...

Date First Received: February 13, 2008

Last Updated: December 9, 2008

Verified by: Allergan, December 2008

Clinical Trial Phase: N/A | Start Date: December 2007

Overall Status: Completed

Estimated Enrollment: 399

Brief Summary

Condition Keyword(s):

Topical fluoroquinolones (FQs) have achieved widespread use in ophthalmology for both the treatment and prophylaxis of ocular infections. The present study is set to determine the bacteria present on the ocular surface in patients at the time of cataract surgery and to assess the rate of resistance of ocular isolates to commonly used topical antibiotics.

Study Type: Observational

Study Design: Cohort, Prospective

Study Primary Completion Date: October 2008

Arms, Groups and Cohorts in this Clinical Trial

  • : A

Outcome Measures for this Clinical Trial

Primary Measures

  • In-vitro time Antibiotic potency
    • Time Frame: Baseline Specimen
      Safety Issue?: No

Secondary Measures

  • In-vitro time to bacteria eradication
    • Time Frame: Baseline Specimen
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Male or female aged 55 or older
  • Scheduled to undergo cataract surgery
  • Able to provide written informed consent

Exclusion Criteria:

  • NSAID in the eye to be swabbed within the past 30 days
  • Topical anesthetic, topical antibiotic or antiseptic, or dilating drops in the eye to the swabbed within the past 7 days
  • Over-the-counter artificial tear drops or astringent /redness reliever drops (e.g., Visine®, Clear eyes® in the eye to be swabbed on the day of trial
  • History of conjunctivitis or any ocular infection within the past 3 months

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: Allergan

Overall Clinical Trial Officials and Contacts

Medical Director Study Director Allergan  

Additional Information

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00621933

Study ID Number: MA-Zymar-08-001

ClinicalTrials.gov Identifier: NCT00621933

Health Authority: United States: Institutional Review Board

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