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

This study has been terminated.
(Study terminated due to lack of enrollment.)
Sponsor:
Collaborator:
Vistakon Pharmaceuticals
Information provided by:
Santen Inc.
ClinicalTrials.gov Identifier:
NCT00764582
First received: September 26, 2008
Last updated: August 24, 2009
Last verified: August 2009
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
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:

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
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 Name: 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 Name: VIGAMOX

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

Keywords provided by Santen Inc.:
Corneal penetration of levofloxacin and moxifloxacin

Additional relevant MeSH terms:
Eye Injuries, Penetrating
Eye Injuries
Facial Injuries
Craniocerebral Trauma
Wounds and Injuries
Wounds, Penetrating
Ofloxacin
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013