Ocular Penetration of 1.5% Levofloxacin and 0.5% Moxifloxacin During Corneal Transplant Surgery
Information source: Santen Inc.
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Corneal Transplantation
Intervention: 1.5% levofloxacin ophthalmic solution (Drug); 0.5% moxifloxacin ophthalmic solution (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Santen Inc. Overall contact:
Brian L. Schwarm, MD, Email: bschwam@visus.jnj.com
Summary
Compare the corneal penetration of levofloxacin 1. 5% and moxifloxacin 0. 5% in patients
undergoing penetrating keratoplasty (PK)
Clinical Details
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
Study design: Basic Science, Randomized, Single Blind (Investigator), Parallel Assignment, Pharmacokinetics Study
Primary outcome: Concentration of levofloxacin and moxifloxacin in the corneal tissue
Secondary outcome: Adverse Events
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Brian L. Schwarm, MD, Email: bschwam@visus.jnj.com
Vistakon, Jacksonville, Florida 32216, United States; Recruiting
Additional Information
Starting date: September 2008
Last updated: October 1, 2008
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