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

Bausch + Lomb

Status and phase: Completed; Phase 1

Conditions: Cataract Extraction

Treatments: Drug: moxifloxacin hydrochloride; Drug: gatifloxacin; Drug: Besifloxacin hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00824070

575

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 3 patient groups

Besifloxacin

Experimental group

Description:

Besifloxacin ophthalmic suspension

Treatment:

Drug: Besifloxacin hydrochloride

Moxifloxacin

Active Comparator group

Description:

Vigamox (moxifloxacin ophthalmic solution, 0.5%)

Treatment:

Drug: moxifloxacin hydrochloride

Gatifloxacin

Active Comparator group

Description:

Zymar (gatifloxacin ophthalmic solution, 0.3%)

Treatment:

Drug: gatifloxacin