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

NCT00824070 — Phase 1, Completed, 105 participants, Bausch & Lomb Incorporated

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An Open-Label, Randomized Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects After a Single Topical Dose

Registry	NCT00824070
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: none, screening
Enrollment	105 (Actual)
Sponsor	Bausch & Lomb Incorporated (Industry)
Conditions	Cataract Extraction
Interventions	Besifloxacin hydrochloride, moxifloxacin hydrochloride, gatifloxacin (Drug)
Dates	start 2009-02-01, primary completion 2009-07-01, completion 2009-08-01, first posted 2009-01-16, last updated 2011-12-13
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Besifloxacin	Experimental	Drug: Besifloxacin hydrochloride	Besifloxacin ophthalmic suspension
Moxifloxacin	Active comparator	Drug: moxifloxacin hydrochloride	Vigamox (moxifloxacin ophthalmic solution, 0.5%)
Gatifloxacin	Active comparator	Drug: gatifloxacin	Zymar (gatifloxacin ophthalmic solution, 0.3%)

Besifloxacin hydrochloride (Drug), also known as Besivance: Instill besifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.
moxifloxacin hydrochloride (Drug), also known as Vigamox: Instill moxifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.
gatifloxacin (Drug), also known as Zymar: Instill gatifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.

+Outcome measures

Primary outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Posted results

Participant flow

Milestone	Besifloxacin	Moxifloxacin	Gatifloxacin
Started	34	35	36
Completed	34	35	36
Not completed	0	0	0

Outcome results

The Aqueous Humor Drug Concentration. (Primary), Mean, µg/mL: Besifloxacin 0.1349 +/- 0.5820; Moxifloxacin 0.6681 +/- 0.4980; Gatifloxacin 0.1251 +/- 0.07624

Adverse events

Time frame: Single ocular administration

Arm	Serious adverse events	Other adverse events
Besifloxacin	0/34 (0.0%)	0/34 (0.0%)
Moxifloxacin	0/35 (0.0%)	0/35 (0.0%)
Gatifloxacin	0/36 (0.0%)	0/36 (0.0%)

Limitations and caveats: All drug concentrations were significantly below MIC90 values for relevant staphylococcal species.

+Locations (1)

Facility	City	Country	Status
Ophthalmic Consultants of Long Island	Rockville Centre, New York	United States

+Investigators

Eric Donnefeld, Principal investigator, Ophthalmic Consultants of Long Island