Expired Study
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Salt Lake City, Utah


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.


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


Study is Available At:


Original ID:

MA-Zymar-08-001


NCT ID:

NCT00621933


Secondary ID:


Study Acronym:


Brief Title:

Surveillance of Ocular Surface Flora (SURFACE)


Official Title:


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

50 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Allergan


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

399


Enrollment Type:

Actual


Overall Contact Information

Official Name:Medical Director
Study Director
Allergan

Study Dates

Start Date:December 2007
Completion Date:November 2008
Completion Type:Actual
Primary Completion Date:October 2008
Primary Completion Type:Actual
Verification Date:April 2019
Last Changed Date:April 10, 2019
First Received Date:February 13, 2008
First Results Date:October 17, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Eyelid
Time Frame:Baseline
Safety Issues:False
Description: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 o
Outcome Type:Primary Outcome
Measure:Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Conjunctiva
Time Frame:Baseline
Safety Issues:False
Description: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 concentra
Outcome Type:Secondary Outcome
Measure:Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Eyelid
Time Frame:Baseline
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Conjunctiva
Time Frame:Baseline
Safety Issues:False
Description: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 o

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:All Patients Receiving Cataract Surgery
Description:All Patients Receiving Cataract Surgery

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Allergan

Samples and Retentions

Sample Retention:Samples Without DNA
Description: Culture Swabs of the conjunctiva and eyelids
Study Population: Cataract Surgery Patients
Sample Method:Probability Sample

Study References

Reference Type:Reference
Citation:Olson R, Donnenfeld E, Bucci FA Jr, Price FW Jr, Raizman M, Solomon K, Devgan U, Trattler W, Dell S, Wallace RB, Callegan M, Brown H, McDonnell PJ, Conway T, Schiffman RM, Hollander DA. Methicillin resistance of Staphylococcus species among health care and nonhealth care workers undergoing cataract surgery. Clin Ophthalmol. 2010 Dec 10;4:1505-14. doi: 10.2147/OPTH.S14333.
PMID:21191448

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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