Dosage Study for Vigamox Eye Drops Prior to Intravitreal Injections

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...

Date First Received: May 30, 2008

Last Updated: June 3, 2008

Verified by: Illinois Retina Associates, May 2008

Clinical Trial Phase: Phase 4 | Start Date: July 2008

Overall Status: Not yet recruiting

Estimated Enrollment: 40

Brief Summary

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”

Condition Keyword(s):

Intervention(s):

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

Study Primary Completion Date: June 2009

Intervention(s) in this Clinical Trial

  • Drug: Vigamox
    • eye drops 3 times day either 1 or 3 days prior to intravitreal injection

Arms, Groups and Cohorts in this Clinical Trial

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

Outcome Measures for this Clinical Trial

Primary Measures

  • Timed study
    • Time Frame: 1 year
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: Illinois Retina Associates

Overall Clinical Trial Officials and Contacts

Kourous A Rezaei, MD Principal Investigator Illinois Retina Associates SC  

Overall Contact: Kourous A Rezaei, MD 708-596-8710 karezaei@yahoo.com

Additional Information

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00690313

Study ID Number: Vig508

ClinicalTrials.gov Identifier: NCT00690313

Health Authority: United States: Institutional Review Board

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