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”

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

Study Type: Interventional

Study Design: Basic Science, Randomized, Single Blind (Investigator), Parallel Assignment, Pharmacokinetics Study

Study Primary Completion Date: March 2009

Intervention(s) in this Clinical Trial

• 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
• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• Concentration of levofloxacin and moxifloxacin in the corneal tissue
  • Time Frame: Time of surgery
    Safety Issue?: No

Secondary Measures

• Adverse Events
  • Time Frame: 4 days
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Santen Inc.

Overall Clinical Trial Officials and Contacts

Overall Contact: Brian L. Schwarm, MD  bschwam@visus.jnj.com

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00764582

Study ID Number: VPH0109

ClinicalTrials.gov Identifier: NCT00764582

Health Authority: United States: Institutional Review Board