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Surveillance of Ocular Surface Flora (SURFACE)

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ClinicalTrials.gov Identifier: NCT00621933
Recruitment Status : Completed
First Posted : February 22, 2008
Results First Posted : July 18, 2012
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Cataract
Enrollment 399
Recruitment Details  
Pre-assignment Details This was a culture swab study at a single time-point. No medications were administered and patients were not followed beyond the initial culture.
Arm/Group Title All Patients
Hide Arm/Group Description All patients receiving cataract surgery
Period Title: Overall Study
Started 399
Completed 399
Not Completed 0
Arm/Group Title All Patients
Hide Arm/Group Description All patients receiving cataract surgery
Overall Number of Baseline Participants 399
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 399 participants
< 50 years 6
Between 50 and 59 years 61
Between 60 and 69 years 126
Between 70 and 79 years 138
Between 80 and 89 years 60
Between 90 and 99 years 8
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 399 participants
Female
224
  56.1%
Male
175
  43.9%
1.Primary Outcome
Title Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Eyelid
Hide 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 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).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. All patients with cultures performed of the ocular surface.
Arm/Group Title All Patients
Hide Arm/Group Description:
All patients receiving cataract surgery
Overall Number of Participants Analyzed 399
Measure Type: Number
Unit of Measure: Percentage of Species
Percentage of Species Oxacillin-Susceptible 51
Percentage of Species Oxacillin-Resistant 48
2.Primary Outcome
Title Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Conjunctiva
Hide 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 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).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. All patients with cultures performed of the ocular surface.
Arm/Group Title All Patients
Hide Arm/Group Description:
All patients receiving cataract surgery
Overall Number of Participants Analyzed 399
Measure Type: Number
Unit of Measure: Percentage of Species
Percentage of Species Oxacillin-Susceptible 52
Percentage of Species Oxacillin-Resistant 45
3.Secondary Outcome
Title Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Eyelid
Hide 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 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).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. All patients with cultures performed of the ocular surface.
Arm/Group Title All Patients
Hide Arm/Group Description:
All patients receiving cataract surgery
Overall Number of Participants Analyzed 399
Measure Type: Number
Unit of Measure: Percentage of Species
Percentage of Species Oxacillin-Susceptible 59
Percentage of Species Oxacillin-Resistant 34
4.Secondary Outcome
Title Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Conjunctiva
Hide 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 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).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. All patients with cultures performed of the ocular surface.
Arm/Group Title All Patients
Hide Arm/Group Description:
All patients receiving cataract surgery
Overall Number of Participants Analyzed 399
Measure Type: Number
Unit of Measure: Percentage of Species
Percentage of Species Oxacillin-Susceptible 70
Percentage of Species Oxacillin-Resistant 21
Time Frame [Not Specified]
Adverse Event Reporting Description Serious adverse events and adverse events were not collected/assessed.
 
Arm/Group Title All Patients
Hide Arm/Group Description All patients receiving cataract surgery
All-Cause Mortality
All Patients
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Patients
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Patients
Affected / at Risk (%)
Total   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Vice President, Medical Affairs
Organization: Allergan, Inc
Phone: 714-246-4500
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00621933     History of Changes
Other Study ID Numbers: MA-Zymar-08-001
First Submitted: February 13, 2008
First Posted: February 22, 2008
Results First Submitted: October 17, 2011
Results First Posted: July 18, 2012
Last Update Posted: April 26, 2019