Status:
COMPLETED
Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Cataract Extraction
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is being conducted to assess the concentration of besifloxacin, moxifloxacin, or gatifloxacin in aqueous humor samples collected following topical instillation of the associated formulation...
Eligibility Criteria
Inclusion
- Subjects who are a candidate for a routine, uncomplicated, primary cataract extraction.
- Subjects who, in the Investigator's opinion, have potential for postoperative best corrected Snellen visual acuity of at least 20/200 in the study eye.
Exclusion
- Subjects who have a known sensitivity, contraindication, or allergy to the study medication(s) or their components.
- Subjects who had any corneal refractive surgery in the study eye.
- Subjects who have a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result of the study.
- Subjects who had ocular surgery in the study eye, including laser procedures, within the past 6 months.
- Subjects who have taken any topical ocular medication in the study eye, other than those required by the protocol and permitted for surgery, during the 24 hours prior to the study medication being instilled.
- Subjects who use any antibiotics (e.g., systemic or topical) within the 7 days prior to the surgery date.
- Subjects who are monocular.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00824070
Start Date
February 1 2009
End Date
August 1 2009
Last Update
December 13 2011
Active Locations (1)
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1
Ophthalmic Consultants of Long Island
Rockville Centre, New York, United States, 11570