Aqueous Absorption and Pharmacokinetics of Besivance Versus VIGAMOX in Patients Undergoing Phacoemulsification

• Sponsor: Frank A. Bucci, Jr., M.D. (Other)
• Overall Status: Completed
• CT.gov ID: NCT01296191
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Duration (Months): 20.1
• Patients Per Site Per Month: 6

Study Details

Study Description

Brief Summary

The purpose of this study is to compare drug concentrations in aqueous humor following ocular instillation of Besivance and VIGAMOX in subjects undergoing cataract surgery.

Condition or Disease	Intervention/Treatment	Phase
Cataracts	Drug: Moxifloxacin; Drug: besifloxacin	Phase 4

Detailed Description

The objective of this study is to compare drug concentrations in aqueous humor following ocular instillation of Besivance or VIGAMOX in subjects undergoing cataract surgery. The hypothesis of the study is that the aggregate aqueous absorption of Besivance over a six hour period is greater than VIGAMOX because of unique properties of Besivance which promote increased contact time of this antibiotic with the ocular surface.

Subjects with scheduled cataract surgery will be screened during their pre-operative visit. Eligible subjects will be randomized to treatment with Besivance or VIGAMOX. Subjects will self-administer 1 drop of study drug into the operative eye 4 times a day for 3 days prior to surgery.Subjects will have one final drop of study medication on the day of surgery.Immediately prior to beginning the cataract surgery, a sample of aqueous humor will be collected by paracentesis.Concentration of Besivance and VIGAMOX in the aqueous humor will be determined by an independent laboratory using standardized high pressure liquid chromatography and mass spectrometry assays. Pharmacokinetic parameters determined from the aqueous humor concentration-time data will minimally include the area under the curve and the maximum concentration.

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: Aqueous Absorption and Pharmacokinetics of Besivance Versus VIGAMOX in Patients Undergoing Phacoemulsification
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: VIGAMOX Subjects undergoing cataract surgery, randomized to the VIGAMOX group Generic name is moxifloxacin eye drops, drops to be used 1 drop 4 times daily for 3 days prior to surgery and 1 drop on day of surgery.	Drug: Moxifloxacin; One drop 4 times daily for 3 days and one drop the day of sample collection; Other Names: Vigamox
Active Comparator: Besivance Subjects scheduled for cataract surgery, randomized to the Besivance group Generic name is besifloxacin eye drops, drops to be used 1 drop 4 times daily for 3 days prior to surgery and 1 drop on day of surgery.	Drug: besifloxacin; One drop 4 times daily for 3 days and one drop on day of sample collection; Other Names: Besivance

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics in Aqueous Humor Samples. [Measured after 3 days of drug instillation]

   Concentration of Besivance and VIGAMOX in the aqueous humor will be determined by an independent laboratory using standardized high-pressure liquid chromatography and mass spectrometry assays. Pharmacokinetic parameters determined from the aqueous humor concentration will minimally include the area under the curve and the maximum concentration.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Man or woman 18 years of age or older.

• Physically capable of instilling eye drop or have an appropriate person available to assist in administration of eye drops 4 times a day.

• Scheduled for phacoemulsification with intraocular lens (IOL) implantation for the treatment of cataract.

• Meet the American Society of Anesthesiology (ASA) physical status I, II, or III and be medically cleared for surgery.

• Willing to adhere to the prohibitions and restrictions specified in this protocol.

• Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

• Known allergy or contraindication to the test article(s) or their components.

• Presence of any abnormality or significant illness in the eye that in the investigator's opinion could affect the subject's health or the study parameters.

• Presence of an active ocular infection (bacterial, viral or fungal), or positive history of ocular herpetic infection.

• History of any significant illness that could be expected to interfere with the study parameters. Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study.

• Use of disallowed therapies (systemic or topical):

• Fluoroquinolone anti-infective agents (systemic or topical) within 1 week of Visit 1 or anytime after Visit 1 for the duration of the study.

• Use of contact lenses for one week prior to the study and for the duration of the study.

• Received an experimental drug or used an experimental medical device within 10 days before the planned start of treatment.

• Breast-feeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bucci Laser Vision Institute	Wilkes-Barre	Pennsylvania	United States	18702

Sponsors and Collaborators

• Frank A. Bucci, Jr., M.D.

Investigators

• Principal Investigator: Frank A. Bucci, Jr., MD, Bucci Laser Vision Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Frank A. Bucci, Jr., M.D., Principal Investigator, Bucci Laser Vision Institute
• ClinicalTrials.gov Identifier: NCT01296191
• Other Study ID Numbers: 2011-BV-A
• First Posted: Feb 15, 2011
• Last Update Posted: Dec 22, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Cataract; Moxifloxacin; Besifloxacin

Study Results

Participant Flow

Arm/Group Title	VIGAMOX	Besivance
Arm/Group Description	Subjects undergoing cataract surgery, randomized to the VIGAMOX group	Subjects scheduled for cataract surgery, randomized to the Besivance group
Period Title: Overall Study
STARTED	60	60
COMPLETED	57	59
NOT COMPLETED	3	1

Baseline Characteristics

Arm/Group Title	VIGAMOX	Besivance	Total
Arm/Group Description	Subjects undergoing cataract surgery, randomized to the VIGAMOX group	Subjects scheduled for cataract surgery, randomized to the Besivance group	Total of all reporting groups
Overall Participants	60	60	120
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	9 15%	12 20%	21 17.5%
>=65 years	51 85%	48 80%	99 82.5%
Sex: Female, Male (Count of Participants)
Female	35 58.3%	28 46.7%	63 52.5%
Male	25 41.7%	32 53.3%	57 47.5%

Outcome Measures

1. Primary Outcome

Title	Pharmacokinetics in Aqueous Humor Samples.
Description	Concentration of Besivance and VIGAMOX in the aqueous humor will be determined by an independent laboratory using standardized high-pressure liquid chromatography and mass spectrometry assays. Pharmacokinetic parameters determined from the aqueous humor concentration will minimally include the area under the curve and the maximum concentration.
Time Frame	Measured after 3 days of drug instillation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	VIGAMOX	Besivance
Arm/Group Description	Subjects undergoing cataract surgery, randomized to the VIGAMOX group	Subjects scheduled for cataract surgery, randomized to the Besivance group
Measure Participants	57	59
Mean (Standard Deviation) [ng/ml]	443.07 (232.285)	56.4525 (39.6325)

Adverse Events

Time Frame	Adverse events were collected from the start of the study medications until the aqueous collection. This time period is 4 days.
Arm/Group Title	VIGAMOX		Besivance
Arm/Group Description	Subjects undergoing cataract surgery, randomized to the VIGAMOX group		Subjects scheduled for cataract surgery, randomized to the Besivance group
All Cause Mortality
	VIGAMOX		Besivance
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	VIGAMOX		Besivance
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/60 (0%)
Other (Not Including Serious) Adverse Events
	VIGAMOX		Besivance
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/60 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.