NCT00350363

Brief Summary

Comparison of 1 day versus 1 hour application of topical Zymar.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_4

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

July 5, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 10, 2006

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

January 29, 2015

Completed
Last Updated

January 29, 2015

Status Verified

January 1, 2015

Enrollment Period

3.9 years

First QC Date

July 5, 2006

Results QC Date

May 15, 2014

Last Update Submit

January 26, 2015

Conditions

Ophthalmic Surgery

Outcome Measures

Primary Outcomes (1)

  • Number of Participant With Positive Culture

    2 weeks

Study Arms (1)

1 hour gatifloxacin

ACTIVE COMPARATOR

presence of conjunctival bacteria 1 hour after administration of topical gatifloxacin

Drug: Zymar

Interventions

ZymarDRUG

zymar qid

Also known as: gatifloxacin
1 hour gatifloxacin

Eligibility Criteria

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

You may qualify if:

  • ophthalmic surgery

You may not qualify if:

  • taken antibiotics, allergic to fluoroquinolones

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
650-723-6995

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
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

July 5, 2006

First Posted

July 10, 2006

Study Start

January 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

January 29, 2015

Results First Posted

January 29, 2015

Record last verified: 2015-01

Locations

US(1)