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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

Page last updated: August 23, 2015

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