NCT00347828

Brief Summary

The purpose of this study is to analyze the effect of Zymar and Vigamox on ocular surface bacteria. We believe that Zymar will eradicate more ocular surface bacteria than Vigamox.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
Last Updated

July 4, 2006

Status Verified

June 1, 2006

First QC Date

June 30, 2006

Last Update Submit

July 3, 2006

Conditions

Eye InfectionInfection

Keywords

Antibiotic prophylaxisVigamoxMoxifloxacinZymarGatifloxacinPreoperative antibioticEye infection

Outcome Measures

Primary Outcomes (4)

  • Evidence of growth and number of colonies of bacteria on chocolate agar prior to antibiotic administration, t=0 hrs

  • Evidence of growth and number of colonies of bacteria on blood agar prior to antibiotic administration, t=0 hrs

  • Evidence of growth and number of colonies of bacteria on chocolate agar post-antibiotic administration, t=1 hr

  • Evidence of growth and number of colonies of bacteria on blood agar post-antibiotic administration, t=1 hr

Interventions

Moxifloxacin ophthalmic solution 0.5%DRUG
Gatifloxacin ophthalmic solution 0.3%DRUG

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female 25 years of age or older
  • Informed consent
  • Likely to complete the entire course of the study

You may not qualify if:

  • Contraindications or known sensitivity to any component of the study medications
  • A subject on oral or topical antibiotics
  • A subject that has a condition (i.e. an uncontrolled systemic disease) or is in a situation which, in the investigator's opinion, may put the subject at significant risk, may confound the trial results, or may interfere significantly with the subject's participation in the trial.
  • Monocular subjects
  • Contact lens wearers
  • Subjects who regularly take eyedrops other than preservative free artificial tears
  • A subject with an eye infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Eye InfectionsInfections

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Michael B Raizman, B.A./M.D.

    Ophthalmic Consultants of Boston

    PRINCIPAL INVESTIGATOR

  • Sandra Y Cho, B.A./M.D.

    New England Eye Center/Tufts-New England Medical Center

    STUDY DIRECTOR

  • Rahul Mandiga, B.S.

    New England Eye Center/Tufts-New England Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 30, 2006

First Posted

July 4, 2006

Study Start

June 1, 2006

Study Completion

June 1, 2006

Last Updated

July 4, 2006

Record last verified: 2006-06

Locations

US(1)