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

Phase 1

Completed

• Conditions: Cataract Extraction
• Interventions: Drug: Besifloxacin hydrochloride; Drug: moxifloxacin hydrochloride; Drug: gatifloxacin

• Registration Number: NCT00824070
• Lead Sponsor: Bausch & Lomb Incorporated

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 in subjects undergoing cataract surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-01-15
• Study First Submitted QC: 2009-01-15
• Study First Posted: 2009-01-16
• Study Start: 2009-02
• Primary Completion: 2009-07
• Study Completion: 2009-08
• Results First Submitted: 2010-09-30
• Results First Submitted QC: 2010-09-30
• Results First Posted: 2010-10-29
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-07
• Last Update Posted: 2011-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Besifloxacin	Besifloxacin hydrochloride	Besifloxacin ophthalmic suspension
Moxifloxacin	moxifloxacin hydrochloride	Vigamox (moxifloxacin ophthalmic solution, 0.5%)
Gatifloxacin	gatifloxacin	Zymar (gatifloxacin ophthalmic solution, 0.3%)

Primary Outcome Measures

Name	Time	Method
The Aqueous Humor Drug Concentration.	Visit 2, 1-14 days following screening visit	An aqueous humor specimen was collected from the study eye for determination of drug concentration 60 min after study drug instillation.

Trial Locations

Locations (1)

Ophthalmic Consultants of Long Island; 🇺🇸 Rockville Center, New York, United States