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

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

Official Title
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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

Conditions
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Corneal Transplantation

Intervention / Treatment
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* Drug: 1.5% levofloxacin ophthalmic solution
* Drug: 0.5% moxifloxacin ophthalmic solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: 1.5% levofloxacin ophthalmic solution<br>* 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<br>* Other names: IQUIX;|
| Active Comparator: 2<br> | Drug: 0.5% moxifloxacin ophthalmic solution<br>* 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<br>* Other names: VIGAMOX;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of levofloxacin and moxifloxacin in the corneal tissue |  | Time of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Corneal penetration of levofloxacin and moxifloxacin