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Change in Ocular Flora Resistance From Repeated Topical Antibiotic Use

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Dr. Peter Kertes, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01181713
First received: February 8, 2010
Last updated: December 2, 2011
Last verified: December 2011
History of Changes
  Purpose

The purpose of this study is to determine if antibiotic resistance of the ocular surface flora to the 4th generation fluoroquinolones will increase after repeated use of topical antibiotics for three days post intravitreal injection.


Condition
Increased Drug Resistance
Infection Resistant to Quinolones and Fluoroquinolones

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Antibiotic Resistance of Ocular Surface Flora After Continued Use of Topical Antibiotics Post Intravitreal Injections

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • ocular flora resistance to 4th generation fluoroquinolone [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Outcome will examine the change in amount, type and antibiotic resistance profile of ocular surface flora over the 3 months. Charcoal swab of the conjunctiva will be cultured, organisms grown will be identified and resistance to moxifloxacin will be quantified by minimal inhibitory resistance (MIC).


Estimated Enrollment: 168
Study Start Date: June 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
No Antibiotic
No prophylactic antibiotic post intravitreal injection
Prophylactic Antibiotic
Group treated with 3 day course of prophylactic topic antibiotic, fourth generation fluoroquinolones, after each intravitreal injection

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient recruitment would be from the Sunnybrook Health and Sciences Centre Department of Ophthalmology

Criteria

Inclusion Criteria:

  • patients scheduled for intravitreal injection for neovascular age-related macular degeneration (ARMD)
  • 65 years or older
  • able to provide informed consent.

Exclusion Criteria:

  • diagnosed with an active ocular, periocular or systemic infection
  • previously received treatment with an intravitreal injection
  • previously treated with antibiotics in the past three months
  • unable to attend the scheduled follow-up appointments or to complete treatment for any reason
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01181713

Locations
Canada, Ontario
Sunnybrook Health and Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Novartis
Investigators
Study Chair: Peter Kertes, MD, FRCSC Sunnybrook Health Sciences Centre
Study Director: Vivian T Yin, MD University of Toronto
Study Director: Daniel Weisbrod, MD, FRCSC Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Dr. Peter Kertes, chief, department of ophthalmology, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01181713     History of Changes
Other Study ID Numbers: SBK-OcuFResis
Study First Received: February 8, 2010
Last Updated: December 2, 2011
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013