NCT00335088

Brief Summary

The hypothesis is that povidone iodine alone is sufficient for sterilization of the lacrimal sac and eye lids before intraocular surgeries. Patients admitted for various intraocular surgeries will be randomly allocated to prophylactic local therapy with either moxifloxacin and povidone iodine or povidone iodine alone before surgery. Lacrimal sac and eye lid cultures will be obtained before the local therapy and just before surgery.

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
500

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_3

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
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 8, 2006

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

June 1, 2007

Status Verified

March 1, 2007

First QC Date

June 5, 2006

Last Update Submit

May 31, 2007

Conditions

Eye Infections

Keywords

Prophylaxis,Intraocular surgeryLacrimal sacEye lidNo conditions

Outcome Measures

Primary Outcomes (2)

  • Type and amount of bacterial growth

  • Post surgery infections

Interventions

Moxifloxacin and Povidone Iodine vs Povidone IodineDRUG

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 20 years.
  • Various intraocular surgeries

You may not qualify if:

  • Need for emergency therapy, immunosuppression, any malignancy, psychomotor retardation, drug and alcohol abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmology Department, HaEmek Medical Center, Afula, Israel

Afula, 18101, Israel

RECRUITING

MeSH Terms

Conditions

Eye Infections

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

InfectionsEye Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Dan Miron, MD

    HaEmek Medicak Center, Afula, Israel

    STUDY DIRECTOR

  • Orky Halachmi, MD

    HaEmek Medical Center, Afula, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Orly Halachmi, MD

CONTACT

972-4-649344

Dan Miron, MD

CONTACT

972-4-6404316miron_da@yahoo.om

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 5, 2006

First Posted

June 8, 2006

Study Start

June 1, 2006

Study Completion

May 1, 2007

Last Updated

June 1, 2007

Record last verified: 2007-03

Locations

IL(1)