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Dosage Study for Vigamox Eye Drops Prior to Intravitreal Injections

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ClinicalTrials.gov Identifier: NCT00690313
Recruitment Status : Unknown
Verified May 2008 by Illinois Retina Associates.
Recruitment status was:  Not yet recruiting
First Posted : June 4, 2008
Last Update Posted : June 4, 2008
Sponsor:
Collaborator:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment Phase
Intravitreal Injection Patients Drug: Vigamox Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2008
Estimated Primary Completion Date : June 2009
Estimated Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Timed study [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: June 4, 2008    Key Record Dates
Last Update Posted: June 4, 2008
Last Verified: May 2008

Keywords provided by Illinois Retina Associates:
Vigamox, topical antibiotics, Intravitreal injections, macular degeneration, endophthalmitis

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