Back to results

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

Primary Purpose

Cataracts

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Moxifloxacin

besifloxacin

About this trial

This is an interventional prevention trial for Cataracts

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Bucci Laser Vision Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

VIGAMOX

Besivance

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pharmacokinetics in Aqueous Humor Samples.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01296191

First Posted

February 14, 2011

Last Updated

November 30, 2020

Sponsor

Frank A. Bucci, Jr., M.D.

1. Study Identification

Unique Protocol Identification Number

NCT01296191

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Frank A. Bucci, Jr., M.D.

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataracts

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VIGAMOX

Arm Type

Active Comparator

Arm Description

Arm Title

Besivance

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Moxifloxacin

Other Intervention Name(s)

Vigamox

Intervention Description

One drop 4 times daily for 3 days and one drop the day of sample collection

Intervention Type

Drug

Intervention Name(s)

besifloxacin

Other Intervention Name(s)

Besivance

Intervention Description

One drop 4 times daily for 3 days and one drop on day of sample collection

Primary Outcome Measure Information:

Title

Pharmacokinetics in Aqueous Humor Samples.

Description

Time Frame

Measured after 3 days of drug instillation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frank A. Bucci, Jr., MD

Organizational Affiliation

Bucci Laser Vision Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bucci Laser Vision Institute

City

Wilkes-Barre

State/Province

Pennsylvania

ZIP/Postal Code

18702

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs