Ocular Penetration of 1.5% Levofloxacin and 0.5% Moxifloxacin During Corneal Transplant Surgery - Full Text View

Sponsor:	Santen Inc.
Collaborator:	Vistakon Pharmaceuticals
Information provided by:	Santen Inc.
ClinicalTrials.gov Identifier:	NCT00764582

Purpose

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

Condition	Intervention	Phase
Corneal Transplantation	Drug: 1.5% levofloxacin ophthalmic solution Drug: 0.5% moxifloxacin ophthalmic solution	Phase IV

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Single Blind (Investigator), Parallel Assignment, Pharmacokinetics Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Surgery

Drug Information available for: Ofloxacin Levofloxacin Ofloxacin hydrochloride Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Santen Inc.:

Primary Outcome Measures:

Concentration of levofloxacin and moxifloxacin in the corneal tissue [ Time Frame: Time of surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse Events [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	September 2008
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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
2: Active Comparator	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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00764582

Locations

United States, Florida

Boynton Beach, Florida, United States
United States, Indiana

Indianapolis, Indiana, United States
United States, Michigan

Great Rapids, Michigan, United States
United States, Missouri

Kansas City, Missouri, United States

Springfield, Missouri, United States
United States, New York

Stony Brook, New York, United States
United States, Ohio

Cincinnati, Ohio, United States
United States, Oregon

Portland, Oregon, United States

Sponsors and Collaborators

Santen Inc.

Vistakon Pharmaceuticals

More Information

No publications provided

Responsible Party:	VISTAKON Pharmaceuticals ( Brian Schwam, MD )
Study ID Numbers:	VPH0109
Study First Received:	September 26, 2008
Last Updated:	August 24, 2009
ClinicalTrials.gov Identifier:	NCT00764582 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Santen Inc.:

Corneal penetration of levofloxacin and moxifloxacin

Additional relevant MeSH terms:

Craniocerebral Trauma
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Ofloxacin
Wounds and Injuries
Disorders of Environmental Origin
Anti-Infective Agents, Urinary
Enzyme Inhibitors
Renal Agents

Pharmacologic Actions
Anti-Bacterial Agents
Facial Injuries
Wounds, Penetrating
Eye Injuries
Moxifloxacin
Eye Injuries, Penetrating
Therapeutic Uses
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010