Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects

Cataract Extraction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00824070
• Other study ID #: 575
• Status: Completed
• Phase: Phase 1
• First received: January 15, 2009
• Last updated: December 7, 2011
• Start date: February 2009
• Est. completion date: August 2009

Study information

• Verified date: December 2011
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: August 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Cataract Extraction

Intervention

Drug:
• Besifloxacin hydrochloride
Instill besifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.
• moxifloxacin hydrochloride
Instill moxifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.
• gatifloxacin
Instill gatifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.

Locations

Country	Name	City	State
United States	Ophthalmic Consultants of Long Island	Rockville Center	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Aqueous Humor Drug Concentration.	An aqueous humor specimen was collected from the study eye for determination of drug concentration 60 min after study drug instillation.	Visit 2, 1-14 days following screening visit	No