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Surveillance of Ocular Surface Flora (SURFACE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00621933
First received: February 13, 2008
Last updated: July 16, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition
Cataract

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Eyelid [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Percentage of staphylococcus epidermidis species susceptible and resistant to oxacillin on the eyelid. The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus epidermidis, the oxacillin MIC breakpoints were <= 0.25 ug/ml (susceptible) and >= 0.50 ug/ml (resistant).

  • Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Conjunctiva [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Percentage of staphylococcus epidermidis species susceptible and resistant to oxacillin on the conjunctiva . The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus epidermidis, the oxacillin MIC breakpoints were <= 0.25 ug/ml (susceptible) and >= 0.50 ug/ml (resistant).


Secondary Outcome Measures:
  • Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Eyelid [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Percentage of staphylococcus aureus species susceptible and resistant to oxacillin on the eyelid. The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus aureus, the oxacillin MIC breakpoints were <= 2 ug/ml (susceptible) and >= 4 ug/ml (resistant).

  • Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Conjunctiva [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Percentage of staphylococcus aureus species susceptible and resistant to oxacillin on the conjunctiva. The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus aureus, the oxacillin MIC breakpoints were <= 2 ug/ml (susceptible) and >= 4 ug/ml (resistant).


Biospecimen Retention:   Samples Without DNA

Culture Swabs of the conjunctiva and eyelids


Enrollment: 399
Study Start Date: December 2007
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
All Patients Receiving Cataract Surgery
All Patients Receiving Cataract Surgery

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Cataract Surgery Patients

Criteria

Inclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00621933

Locations
United States, Utah
Salt Lake City, Utah, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00621933     History of Changes
Other Study ID Numbers: MA-Zymar-08-001
Study First Received: February 13, 2008
Results First Received: October 17, 2011
Last Updated: July 16, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013