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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00764582
Other study ID # VPH0109
Secondary ID
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)


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Study Design

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


Related Conditions & MeSH terms


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
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