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

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00824070
• Collaborator: (none)
• Enrollment: 105
• Location: 1
• Arms: 3
• Duration (Months): 5.9
• Patients Per Site Per Month: 17.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract Extraction	Drug: Besifloxacin hydrochloride; Drug: moxifloxacin hydrochloride; Drug: gatifloxacin	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 105 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: An Open-Label, Randomized Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects After a Single Topical Dose
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Jul 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Besifloxacin Besifloxacin ophthalmic suspension	Drug: Besifloxacin hydrochloride; Instill besifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.; Other Names: Besivance
Active Comparator: Moxifloxacin Vigamox (moxifloxacin ophthalmic solution, 0.5%)	Drug: moxifloxacin hydrochloride; Instill moxifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.; Other Names: Vigamox
Active Comparator: Gatifloxacin Zymar (gatifloxacin ophthalmic solution, 0.3%)	Drug: gatifloxacin; Instill gatifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.; Other Names: Zymar

Outcome Measures

Primary Outcome Measures

1. 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 Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ophthalmic Consultants of Long Island	Rockville Center	New York	United States	11570

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Principal Investigator: Eric Donnefeld, Ophthalmic Consultants of Long Island

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT00824070
• Other Study ID Numbers: 575
• First Posted: Jan 16, 2009
• Last Update Posted: Dec 13, 2011
• Last Verified: Dec 1, 2011

• Keywords provided by Bausch & Lomb Incorporated: Bioavailability
• Additional relevant MeSH terms: Cataract; Moxifloxacin; Gatifloxacin; Besifloxacin; Norgestimate, ethinyl estradiol drug combination

Study Results

Participant Flow

Recruitment Details	This study was conducted a 6 sites in the US. This was a single dose study with first patient enrollment on 2/2/2009 and last patient visit was 7/9/2009.
Pre-assignment Detail	105 subjects were screened at Visit 1 and qualified subjects returned on the day of surgery (Visit 2).

Arm/Group Title	Besifloxacin	Moxifloxacin	Gatifloxacin
Arm/Group Description	Besifloxacin ophthalmic suspension	Vigamox (moxifloxacin ophthalmic solution, 0.5%)	Zymar (gatifloxacin ophthalmic solution, 0.3%)
Period Title: Overall Study
STARTED	34	35	36
COMPLETED	34	35	36
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Besifloxacin	Moxifloxacin	Gatifloxacin	Total
Arm/Group Description	Besifloxacin ophthalmic suspension	Vigamox (moxifloxacin ophthalmic solution, 0.5%)	Zymar (gatifloxacin ophthalmic solution, 0.3%)	Total of all reporting groups
Overall Participants	34	35	36	105
Age, Customized (participants) [Number]
<60 years	4 (8.1) 11.8%	4 (9.9) 11.4%	5 (9.6) 13.9%	13 12.4%
60-69 years	15 44.1%	7 20%	10 27.8%	32 30.5%
70-79 years	11 32.4%	19 54.3%	14 38.9%	44 41.9%
>/= 80	4 11.8%	5 14.3%	7 19.4%	16 15.2%
Sex: Female, Male (Count of Participants)
Female	18 52.9%	21 60%	20 55.6%	59 56.2%
Male	16 47.1%	14 40%	16 44.4%	46 43.8%
Race/Ethnicity, Customized (participants) [Number]
Caucasian	31 91.2%	33 94.3%	34 94.4%	98 93.3%
Non-Caucasian	3 8.8%	2 5.7%	2 5.6%	7 6.7%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Statistical Analysis of AH Drug Concentration. Modified intent to treat population (mITT). Subjects with non-missing data.

Arm/Group Title	Besifloxacin	Moxifloxacin	Gatifloxacin
Arm/Group Description	Besifloxacin ophthalmic suspension	Vigamox (moxifloxacin ophthalmic solution, 0.5%)	Zymar (gatifloxacin ophthalmic solution, 0.3%)
Measure Participants	32	35	34
Measure eyes	32	35	34
Mean (Standard Deviation) [µg/mL]	0.1349 (0.5820)	0.6681 (0.4980)	0.1251 (0.07624)

Adverse Events

Time Frame	Single ocular administration
Arm/Group Title	Besifloxacin		Moxifloxacin		Gatifloxacin
Arm/Group Description	Besifloxacin ophthalmic suspension		Vigamox (moxifloxacin ophthalmic solution, 0.5%)		Zymar (gatifloxacin ophthalmic solution, 0.3%)
All Cause Mortality
	Besifloxacin		Moxifloxacin		Gatifloxacin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Besifloxacin		Moxifloxacin		Gatifloxacin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/35 (0%)		0/36 (0%)
Other (Not Including Serious) Adverse Events
	Besifloxacin		Moxifloxacin		Gatifloxacin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/35 (0%)		0/36 (0%)

Limitations/Caveats

All drug concentrations were significantly below MIC90 values for relevant staphylococcal species.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are completed. The results of the study may be published or presented by the Investigator(s)after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.