NCT00690313

Brief Summary

Antibiotic eye drops are being used before and after intravitreal injections. Currently there is no study indicating the benefit of there usage or their dosage. In this study we compare the efficacy of Vigamox eye drops (antibiotic)starting 3 days prior to the injection versus 1 day prior to intravitreal injection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2008

Typical duration 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

May 30, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 4, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

2.7 years

First QC Date

May 30, 2008

Last Update Submit

August 5, 2019

Conditions

Intravitreal Injection Patients

Keywords

Vigamox, topical antibiotics, Intravitreal injections, macular degeneration, endophthalmitis

Outcome Measures

Primary Outcomes (1)

  • Timed study

    1 year

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Arm 1: receives Vigamox eye drops 3Xday for 3 days prior to intravitreal injection

Drug: Vigamox

Arm 2

ACTIVE COMPARATOR

Arm 2: receives Vigamox eye drops 3Xday for 1 day prior to intravitreal injection

Drug: Vigamox

Interventions

VigamoxDRUG

eye drops 3 times day either 1 or 3 days prior to intravitreal injection

Arm 1Arm 2

Eligibility Criteria

Age21 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient who need intravitreal injections patients who are willing to participate in the study

You may not qualify if:

  • Patients who are allergic to Vigamox or who have taken any eye drops within the past 3 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Illinois Retina Associates

Harvey, Illinois, 60426, United States

Location

MeSH Terms

Conditions

Macular DegenerationEndophthalmitis

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesEye InfectionsInfections

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Kourous A Rezaei, MD

    Illinois Retina Associates SC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2008

First Posted

June 4, 2008

Study Start

August 1, 2008

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

August 7, 2019

Record last verified: 2019-08

Locations

US(1)