Surveillance of Ocular Surface Flora (SURFACE)

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00621933
• Collaborator: (none)
• Enrollment: 399
• Location: 1
• Duration (Months): 11
• Patients Per Site Per Month: 36.1

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Cataract

Study Design

• Study Type: Observational
• Actual Enrollment: 399 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Study Start Date: Dec 1, 2007
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
All Patients Receiving Cataract Surgery All Patients Receiving Cataract Surgery

Outcome Measures

Primary Outcome Measures

1. Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Eyelid [Baseline]

   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).

2. Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Conjunctiva [Baseline]

   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

1. Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Eyelid [Baseline]

   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).

2. Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Conjunctiva [Baseline]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1		Salt Lake City	Utah	United States

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT00621933
• Other Study ID Numbers: MA-Zymar-08-001
• First Posted: Feb 22, 2008
• Last Update Posted: Apr 26, 2019
• Last Verified: Apr 1, 2019

• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Pre-assignment Detail	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
Arm/Group Description	All patients receiving cataract surgery
Period Title: Overall Study
STARTED	399
COMPLETED	399
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	All Patients
Arm/Group Description	All patients receiving cataract surgery
Overall Participants	399
Age, Customized (participants) [Number]
< 50 years	6 1.5%
Between 50 and 59 years	61 15.3%
Between 60 and 69 years	126 31.6%
Between 70 and 79 years	138 34.6%
Between 80 and 89 years	60 15%
Between 90 and 99 years	8 2%
Sex: Female, Male (Count of Participants)
Female	224 56.1%
Male	175 43.9%

Outcome Measures

1. Primary Outcome

Title	Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Eyelid
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

Outcome Measure Data

Analysis Population Description

ITT population. All patients with cultures performed of the ocular surface.

Arm/Group Title	All Patients
Arm/Group Description	All patients receiving cataract surgery
Measure Participants	399
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
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

Outcome Measure Data

Analysis Population Description

ITT population. All patients with cultures performed of the ocular surface.

Arm/Group Title	All Patients
Arm/Group Description	All patients receiving cataract surgery
Measure Participants	399
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
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

Outcome Measure Data

Analysis Population Description

ITT population. All patients with cultures performed of the ocular surface.

Arm/Group Title	All Patients
Arm/Group Description	All patients receiving cataract surgery
Measure Participants	399
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
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

Outcome Measure Data

Analysis Population Description

ITT population. All patients with cultures performed of the ocular surface.

Arm/Group Title	All Patients
Arm/Group Description	All patients receiving cataract surgery
Measure Participants	399
Percentage of Species Oxacillin-Susceptible	70
Percentage of Species Oxacillin-Resistant	21

Adverse Events

Adverse Event Reporting Description	Serious adverse events and adverse events were not collected/assessed.
Arm/Group Title	All Patients
Arm/Group Description	All patients receiving cataract surgery
All Cause Mortality
	All Patients
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Patients
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	All Patients
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.