Penetrance of Third Generation Fluoroquinolones in Eyes With Functioning Filtering Blebs

Cataract Clinical Trial

Official title:

Penetrance of Third Generation Fluoroquinolones in Eyes With Functioning Filtering Blebs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00392275
• Other study ID #: 0208-29
• Status: Completed
• Phase: Phase 4
• First received: October 23, 2006
• Last updated: April 8, 2013
• Start date: November 2002
• Est. completion date: May 2006

Study information

• Verified date: December 2007
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Based on previous results with eyes without filtering blebs, the aqueous concentrations of ofloxacin and levofloxacin will exceed the concentration of ciprofloxacin after either topical or topical plus oral administration.

Description:

The purpose of this study is to assay human aqueous for concentrations of ofloxacin, ciprofloxacin and levofloxacin after topical or combined topical and oral administration in eyes with filtering blebs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients with functioning filtering blebs will be evaluated prospectively for inclusion

Exclusion Criteria:

• Any subject who is already scheduled to have cataract surgery performed will qualify for participation with the exception of the following exclusion criteria:

• Ongoing ocular inflammatory disease

• Bleb leakage - determined by Seidel test

• Suspected infection

• Known contraindications to use of any of these study medications.

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Drug:
• Ofloxacin 0.3%

• Ciprofloxacin 0.3%

• Levofloxacin 0.5%

• Ofloxacin 400mg

• Ciprofloxacin 400mg

• Levofloxacin 250mg

Locations

Country	Name	City	State
United States	Indiana University Hospital	Indianapolis	Indiana
United States	Richard L Rodeboush VA Medical Center	Indianapolis	Indiana
United States	Wishard Memorial Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (1)

Cantor LB, Donnenfeld E, Katz LJ, Gee WL, Finley CD, Lakhani VK, Hoop J, Flarty K. Penetration of ofloxacin and ciprofloxacin into the aqueous humor of eyes with functioning filtering blebs: a randomized trial. Arch Ophthalmol. 2001 Sep;119(9):1254-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aqueous levels of antibiotics