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

Santen

Status and phase

Terminated

Phase 4

Conditions

Corneal Transplantation

Treatments

Drug: 0.5% moxifloxacin ophthalmic solution

Drug: 1.5% levofloxacin ophthalmic solution

Study type

Interventional

Funder types

Industry

Identifiers

VPH0109

Details and patient eligibility

About

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

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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