Trial Outcomes & Findings for Surveillance of Ocular Surface Flora (SURFACE) (NCT NCT00621933)

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

399 participants

Primary outcome timeframe

Baseline

Results posted on

2019-04-26

Participant Flow

This was a culture swab study at a single time-point. No medications were administered and patients were not followed beyond the initial culture.

Participant milestones

Participant milestones
Measure	All Patients All patients receiving cataract surgery
Overall Study STARTED	399
Overall Study COMPLETED	399
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Surveillance of Ocular Surface Flora (SURFACE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Patients n=399 Participants All patients receiving cataract surgery
Age, Customized < 50 years	6 participants n=93 Participants
Age, Customized Between 50 and 59 years	61 participants n=93 Participants
Age, Customized Between 60 and 69 years	126 participants n=93 Participants
Age, Customized Between 70 and 79 years	138 participants n=93 Participants
Age, Customized Between 80 and 89 years	60 participants n=93 Participants
Age, Customized Between 90 and 99 years	8 participants n=93 Participants
Sex: Female, Male Female	224 Participants n=93 Participants
Sex: Female, Male Male	175 Participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline

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

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).

Outcome measures

Outcome measures
Measure	All Patients n=399 Participants All patients receiving cataract surgery
Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Eyelid Percentage of Species Oxacillin-Susceptible	51 Percentage of Species
Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Eyelid Percentage of Species Oxacillin-Resistant	48 Percentage of Species

PRIMARY outcome

Timeframe: Baseline

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

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).

Outcome measures

Outcome measures
Measure	All Patients n=399 Participants All patients receiving cataract surgery
Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Conjunctiva Percentage of Species Oxacillin-Susceptible	52 Percentage of Species
Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Conjunctiva Percentage of Species Oxacillin-Resistant	45 Percentage of Species

SECONDARY outcome

Timeframe: Baseline

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

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).

Outcome measures

Outcome measures
Measure	All Patients n=399 Participants All patients receiving cataract surgery
Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Eyelid Percentage of Species Oxacillin-Susceptible	59 Percentage of Species
Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Eyelid Percentage of Species Oxacillin-Resistant	34 Percentage of Species

SECONDARY outcome

Timeframe: Baseline

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

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).

Outcome measures

Outcome measures
Measure	All Patients n=399 Participants All patients receiving cataract surgery
Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Conjunctiva Percentage of Species Oxacillin-Susceptible	70 Percentage of Species
Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Conjunctiva Percentage of Species Oxacillin-Resistant	21 Percentage of Species

Adverse Events

All Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vice President, Medical Affairs

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60