Status:
TERMINATED
Ocular Penetration of 1.5% Levofloxacin and 0.5% Moxifloxacin During Corneal Transplant Surgery
Lead Sponsor:
Santen Inc.
Collaborating Sponsors:
Vistakon Pharmaceuticals
Conditions:
Corneal Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Compare the corneal penetration of levofloxacin 1.5% and moxifloxacin 0.5% in patients undergoing penetrating keratoplasty (PK)
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00764582
Start Date
September 1 2008
Last Update
August 26 2009
Active Locations (8)
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1
Boynton Beach, Florida, United States
2
Indianapolis, Indiana, United States
3
Great Rapids, Michigan, United States
4
Kansas City, Missouri, United States