NCT00621933

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
399

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 22, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

July 18, 2012

Completed
Last Updated

April 26, 2019

Status Verified

April 1, 2019

Enrollment Period

10 months

First QC Date

February 13, 2008

Results QC Date

October 17, 2011

Last Update Submit

April 10, 2019

Conditions

Cataract

Outcome Measures

Primary Outcomes (2)

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

    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).

    Baseline

  • Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Conjunctiva

    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).

    Baseline

Secondary Outcomes (2)

  • 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 Conjunctiva

    Baseline

Study Arms (1)

All Patients Receiving Cataract Surgery

All Patients Receiving Cataract Surgery

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Cataract Surgery Patients

You may qualify if:

  • Scheduled to undergo cataract surgery
  • Able to provide written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Salt Lake City, Utah, United States

Location

Related Publications (1)

  • 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: 21191448BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Culture Swabs of the conjunctiva and eyelids

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Results Point of Contact

Title
Vice President, Medical Affairs
Organization
Allergan, Inc
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2008

First Posted

February 22, 2008

Study Start

December 1, 2007

Primary Completion

October 1, 2008

Study Completion

November 1, 2008

Last Updated

April 26, 2019

Results First Posted

July 18, 2012

Record last verified: 2019-04

Locations

US(1)