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

Corneal Transplantation Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00764582
• Other study ID #: VPH0109
• Status: Terminated
• Phase: Phase 4
• First received: September 26, 2008
• Last updated: August 24, 2009
• Start date: September 2008

Study information

• Verified date: August 2009
• Source: Santen Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Corneal Transplantation

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Santen Inc.	Vistakon Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of levofloxacin and moxifloxacin in the corneal tissue		Time of surgery	No
Secondary	Adverse Events		4 days	Yes