Dosage Study for Vigamox Eye Drops Prior to Intravitreal Injections

This study is not yet open for participant recruitment.

Verified by Illinois Retina Associates, May 2008

First Received: May 30, 2008 Last Updated: June 3, 2008 History of Changes

Sponsor:	Illinois Retina Associates
Collaborator:	Alcon Laboratories
Information provided by:	Illinois Retina Associates
ClinicalTrials.gov Identifier:	NCT00690313

Purpose

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.

Condition	Intervention	Phase
Intravitreal Injection Patients	Drug: Vigamox	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	To Compare the Efficacy of Topical Vigamox Eye Drops at Tid 3 Days Prior to Intravitreal Injection Versus Tid 1 Day Prior to Intravitreal Injection

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics

Drug Information available for: Tetrahydrozoline Moxifloxacin Moxifloxacin hydrochloride Tetrahydrozoline hydrochloride

U.S. FDA Resources

Further study details as provided by Illinois Retina Associates:

Primary Outcome Measures:

Timed study [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	July 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Active Comparator Arm 1: receives Vigamox eye drops 3Xday for 3 days prior to intravitreal injection	Drug: Vigamox eye drops 3 times day either 1 or 3 days prior to intravitreal injection
Arm 2: Active Comparator Arm 2: receives Vigamox eye drops 3Xday for 1 day prior to intravitreal injection	Drug: Vigamox eye drops 3 times day either 1 or 3 days prior to intravitreal injection

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00690313

Contacts

Contact: Kourous A Rezaei, MD	708-596-8710	karezaei@yahoo.com
Contact: David J Baczewski	708-915-6808	davidb@illinoisretina.com

Locations

United States, Illinois
Illinois Retina Associates
Harvey, Illinois, United States, 60426

Sponsors and Collaborators

Illinois Retina Associates

Alcon Laboratories

Investigators

Principal Investigator:

Kourous A Rezaei, MD

Illinois Retina Associates SC

More Information

No publications provided

Responsible Party:	Illinois Retina Associates SC ( Kourous Rezaei MD )
Study ID Numbers:	Vig508
Study First Received:	May 30, 2008
Last Updated:	June 3, 2008
ClinicalTrials.gov Identifier:	NCT00690313 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Illinois Retina Associates:

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

Additional relevant MeSH terms:

Anti-Infective Agents
Moxifloxacin
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010