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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Santen Inc.
• Collaborator: Vistakon Pharmaceuticals
• Treatments: Fluoroquinolones; Levofloxacin; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Ofloxacin; Ophthalmic Solutions; Pharmaceutical Solutions

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