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

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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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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