Phase 1
Completed N=105
Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects
Cataract Extraction
Source: ClinicalTrials.gov NCT00824070 ↗
Enrolled (actual)
105
Serious AEs
0.0%
Results posted
Oct 2010
Primary outcomePrimary: The Aqueous Humor Drug Concentration. — 0.1349; 0.6681; 0.1251 µg/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Aqueous Humor Drug Concentration. |
0.1349; 0.6681; 0.1251 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00824070). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.