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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00764582

Enrollment

Registered

2008-10-02

Start date

2008-09-30

Completion date

Unknown

Last updated

2009-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Transplantation

Keywords

Corneal penetration of levofloxacin and moxifloxacin

Brief summary

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

Interventions

DRUG1.5% 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

DRUG0.5% 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Concentration of levofloxacin and moxifloxacin in the corneal tissue	Time of surgery

Secondary

Measure	Time frame
Adverse Events	4 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026