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

NCT00764582 | Terminated Phase 4

• 1 other identifier: VPH0109
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Corneal Transplantation

Keywords

Corneal penetration of levofloxacin and moxifloxacin

Outcome Measures

Primary Outcomes (1)

• Concentration of levofloxacin and moxifloxacin in the corneal tissue

  Time of surgery

Secondary Outcomes (1)

• Adverse Events

  4 days

Study Arms (2)

1

EXPERIMENTAL

Drug: 1.5% levofloxacin ophthalmic solution

2

ACTIVE COMPARATOR

Drug: 0.5% moxifloxacin ophthalmic solution

Interventions

1.5% levofloxacin ophthalmic solution DRUG

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

Also known as: IQUIX

1

0.5% moxifloxacin ophthalmic solution DRUG

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

Also known as: VIGAMOX

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Santen Inc.: lead
• Vistakon Pharmaceuticals: collaborator

Study Sites (8)

Unknown Facility

Boynton Beach, Florida, United States

Location

Unknown Facility

Indianapolis, Indiana, United States

Location

Unknown Facility

Great Rapids, Michigan, United States

Location

Unknown Facility

Kansas City, Missouri, United States

Location

Unknown Facility

Springfield, Missouri, United States

Location

Unknown Facility

Stony Brook, New York, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Portland, Oregon, United States

Location

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: October 2, 2008
• Study Start: September 1, 2008
• Primary Completion: March 1, 2009
• Last Updated: August 26, 2009

Record last verified: 2009-08

Locations

US (8)