Surveillance of Ocular Surface Flora (SURFACE)

This study has been completed.

First Received: February 13, 2008 Last Updated: December 9, 2008 History of Changes

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00621933

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:	Cohort, Prospective

Resource links provided by NLM:

MedlinePlus related topics: Cataract

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

In-vitro time Antibiotic potency [ Time Frame: Baseline Specimen ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

In-vitro time to bacteria eradication [ Time Frame: Baseline Specimen ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

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
A

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:

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

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

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	MA-Zymar-08-001
Study First Received:	February 13, 2008
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00621933 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Eye Diseases
Cataract
Lens Diseases

Additional relevant MeSH terms:

Eye Diseases
Cataract
Lens Diseases

ClinicalTrials.gov processed this record on September 04, 2009