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

Sponsor

Santen Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT00764582

Collaborator

Vistakon Pharmaceuticals (Industry)

Enrollment

Locations

Arms

7.5

Patients Per Site

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Corneal Transplantation	Drug: 1.5% levofloxacin ophthalmic solution Drug: 0.5% moxifloxacin ophthalmic solution	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Basic Science

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 Start Date :

Sep 1, 2008

Anticipated Primary Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	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 Other Names: IQUIX
Active Comparator: 2	Drug: 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 Other Names: VIGAMOX

Arm

Intervention/Treatment

Experimental: 1

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

Other Names:

IQUIX

Active Comparator: 2

Drug: 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

Other Names:

VIGAMOX

Outcome Measures

Primary Outcome Measures

Concentration of levofloxacin and moxifloxacin in the corneal tissue [Time of surgery]

Secondary Outcome Measures

Adverse Events [4 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	State	Country
1	Boynton Beach	Florida	United States
2	Indianapolis	Indiana	United States
3	Great Rapids	Michigan	United States
4	Kansas City	Missouri	United States
5	Springfield	Missouri	United States
6	Stony Brook	New York	United States
7	Cincinnati	Ohio	United States
8	Portland	Oregon	United States