NCT00410891

Brief Summary

Evaluation of efficacy of topical preoperative antibiotics in patients undergoing intravitreous injections.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2008

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

First Submitted

Initial submission to the registry

October 2, 2006

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 13, 2006

Completed
1.6 years until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

June 12, 2014

Completed
Last Updated

November 6, 2017

Status Verified

October 1, 2017

Enrollment Period

1.4 years

First QC Date

October 2, 2006

Results QC Date

May 13, 2014

Last Update Submit

October 4, 2017

Conditions

IntravitreousInjections

Outcome Measures

Primary Outcomes (1)

  • Positive Culture

    The percentage of patients with a positive bacterial culture following administration of study treatment is presented.

    Study day 1, assessed following administration of study treatment

Study Arms (1)

topical antibiotic

EXPERIMENTAL

topical gatifloxacin 4 times per day

Drug: gatifloxacin

Interventions

gatifloxacinDRUG
topical antibiotic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • intravitreous injection

You may not qualify if:

  • antibiotic use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford

Stanford, California, 94304, United States

Location

MeSH Terms

Interventions

Gatifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Professor
Organization
Stanford
cta@stanford.edu
6504984791

Study Officials

  • Christopher Ta, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

October 2, 2006

First Posted

December 13, 2006

Study Start

July 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

November 6, 2017

Results First Posted

June 12, 2014

Record last verified: 2017-10

Locations

US(1)