Ocular Penetration of 1.5% Levofloxacin and 0.5% Moxifloxacin During Corneal Transplant Surgery

A Randomized, Observer-masked, Parallel-group, Multicenter Trial Evaluating the Ocular Penetration of 1.5% Levofloxacin Ophthalmic Solution and 0.5% Moxifloxacin Ophthalmic Solution in Subjects Undergoing Corneal Transplant Surgery

Compare the corneal penetration of levofloxacin 1.5% and moxifloxacin 0.5% in patients undergoing penetrating keratoplasty (PK)

Study Overview

• Status: Terminated
• Conditions: Corneal Transplantation
• Intervention / Treatment: Drug: 1.5% levofloxacin ophthalmic solution; Drug: 0.5% moxifloxacin ophthalmic solution

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Boynton Beach, Florida, United States
  • Indiana
    • Indianapolis, Indiana, United States
  • Michigan
    • Great Rapids, Michigan, United States
  • Missouri
    • Kansas City, Missouri, United States
    • Springfield, Missouri, United States
  • New York
    • Stony Brook, New York, United States
  • Ohio
    • Cincinnati, Ohio, United States
  • Oregon
    • Portland, Oregon, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

• Man or woman 18 years of age or older
• Scheduled for corneal transplant surgery
• Patients must be healthy enough to undergo surgery
• Women must be postmenopausal for at least 1 year or surgically sterile incapable of pregnancy
• Women must be abstinent at the discretion of the investigator
• Women practicing an effective method of birth control
• Women agree before entry to continue to use the same method of contraception throughout the study
• Women of childbearing potential must have a negative urine pregnancy test at screening

Exclusion Criteria

• Presence of an active ocular infection or positive history of ocular herpetic infection
• History of severe dry eye syndrome
• Use of contact lenses in the 2 weeks prior to the study and for the duration of the study
• Received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment
• Pregnant or breast feeding
• Employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center as well as family members of the employees or the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: 1.5% levofloxacin ophthalmic solution; Topical application Instill 1 drop two times, 5 minutes apart. Time from last drop to surgery is determined by group. Group 1: 30 minutes prior to surgery Group 2: 1 hour prior to surgery Group 3: 2 hours prior to surgery Group 4: 4 hours prior to surgery; Other Names: IQUIX
Active Comparator: 2	Drug: 0.5% moxifloxacin ophthalmic solution; Topical application Instill 1 drop two times, 5 minutes apart. Time from last drop to surgery is determined by group. Group 5: 30 minutes prior to surgery Group 6: 1 hour prior to surgery Group 7: 2 hours prior to surgery Group 8: 4 hours prior to surgery; Other Names: VIGAMOX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Concentration of levofloxacin and moxifloxacin in the corneal tissue	Time of surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse Events	4 days

Collaborators and Investigators

• Sponsor: Santen Inc.
• Collaborators: Vistakon Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Anticipated): March 1, 2009

Study Registration Dates

• First Submitted: September 26, 2008
• First Submitted That Met QC Criteria: October 1, 2008
• First Posted (Estimate): October 2, 2008

Study Record Updates

• Last Update Posted (Estimate): August 26, 2009
• Last Update Submitted That Met QC Criteria: August 24, 2009
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: Corneal penetration of levofloxacin and moxifloxacin
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Facial Injuries; Wounds, Penetrating; Eye Injuries; Eye Injuries, Penetrating; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Moxifloxacin; Ophthalmic Solutions; Pharmaceutical Solutions; Levofloxacin; Ofloxacin
• Other Study ID Numbers: VPH0109