NCT00392275

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2002

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2006

Completed
Last Updated

April 10, 2013

Status Verified

December 1, 2007

First QC Date

October 23, 2006

Last Update Submit

April 8, 2013

Conditions

Cataract

Keywords

CataractAqueous absorptionFuntioning Filtering Blebs

Outcome Measures

Primary Outcomes (1)

  • Aqueous levels of antibiotics

Interventions

Ofloxacin 0.3%DRUG
Ciprofloxacin 0.3%DRUG
Levofloxacin 0.5%DRUG
Ofloxacin 400mgDRUG
Ciprofloxacin 400mgDRUG
Levofloxacin 250mgDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • Ongoing ocular inflammatory disease
  • Bleb leakage - determined by Seidel test
  • Suspected infection
  • Known contraindications to use of any of these study medications.
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

Richard L Rodeboush VA Medical Center

Indianapolis, Indiana, 46202, United States

Location

Wishard Memorial Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (2)

  • 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. doi: 10.1001/archopht.119.9.1254.

    PMID: 11545629BACKGROUND

  • Cantor LB, WuDunn D, Yung CW, Valluri S, Catoira YP, Hoop JS, Morgan LS. Ocular penetration of levofloxacin, ofloxacin and ciprofloxacin in eyes with functioning filtering blebs: investigator masked, randomised clinical trial. Br J Ophthalmol. 2008 Mar;92(3):345-7. doi: 10.1136/bjo.2007.121541. Epub 2008 Jan 22.

    PMID: 18211932DERIVED

MeSH Terms

Conditions

Cataract

Interventions

OfloxacinCiprofloxacinLevofloxacin

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Louis B Cantor, MD

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2006

First Posted

October 25, 2006

Study Start

November 1, 2002

Study Completion

May 1, 2006

Last Updated

April 10, 2013

Record last verified: 2007-12

Locations

US(3)