Dosage Study for Vigamox Eye Drops Prior to Intravitreal Injections

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified May 2008 by Illinois Retina Associates.
Recruitment status was: Not yet recruiting

Sponsor:

Collaborator:

Alcon Research

Information provided by:

Illinois Retina Associates

ClinicalTrials.gov Identifier:

NCT00690313

First received: May 30, 2008

Last updated: June 3, 2008

Last verified: May 2008

History of Changes

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 4


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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:

Drug Information available for: Tetrahydrozoline hydrochloride Boric acid Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Illinois Retina Associates:

Primary Outcome Measures:

Timed study [ Time Frame: 1 year ]


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
Active Comparator: Arm 1 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
Active Comparator: Arm 2 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 (Adult, Senior)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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	Not yet recruiting
Harvey, Illinois, United States, 60426
Contact: David J Baczewski 708-915-6808 davidb@illinoisretina.com
Principal Investigator: Kourous A Rezaei, MD

Sponsors and Collaborators

Illinois Retina Associates

Alcon Research

Investigators


Principal Investigator:	Kourous A Rezaei, MD	Illinois Retina Associates SC

More Information


Responsible Party:	Kourous Rezaei MD, Illinois Retina Associates SC
ClinicalTrials.gov Identifier:	NCT00690313 History of Changes
Other Study ID Numbers:	Vig508
Study First Received:	May 30, 2008
Last Updated:	June 3, 2008

Keywords provided by Illinois Retina Associates:


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

Additional relevant MeSH terms:


Norgestimate, ethinyl estradiol drug combination Moxifloxacin Fluoroquinolones Ophthalmic Solutions Tetrahydrozoline Contraceptives, Oral, Combined Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Anti-Bacterial Agents Anti-Infective Agents	Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Nucleic Acid Synthesis Inhibitors Pharmaceutical Solutions Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Nasal Decongestants Vasoconstrictor Agents Respiratory System Agents

ClinicalTrials.gov processed this record on June 27, 2017

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