Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects
Information source: Bausch & Lomb Incorporated
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cataract Extraction
Intervention: Besifloxacin hydrochloride (Drug); moxifloxacin hydrochloride (Drug); gatifloxacin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Bausch & Lomb Incorporated Official(s) and/or principal investigator(s):
Eric Donnefeld, Principal Investigator, Affiliation: Ophthalmic Consultants of Long Island
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 in subjects undergoing cataract surgery.
Clinical Details
Official title: An Open-Label, Randomized Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects After a Single Topical Dose
Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
Primary outcome: The Aqueous Humor Drug Concentration.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Ophthalmic Consultants of Long Island, Rockville Center, New York 11570, United States
Additional Information
Starting date: February 2009
Last updated: December 7, 2011
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