NCT01296191

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
6.8 years until next milestone

Results Posted

Study results publicly available

October 29, 2019

Completed
Last Updated

December 22, 2020

Status Verified

November 1, 2020

Enrollment Period

1.7 years

First QC Date

February 14, 2011

Results QC Date

January 24, 2013

Last Update Submit

November 30, 2020

Conditions

Cataracts

Outcome Measures

Primary Outcomes (1)

  • 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.

    Measured after 3 days of drug instillation

Study Arms (2)

VIGAMOX

ACTIVE COMPARATOR

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

Besivance

ACTIVE COMPARATOR

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

Interventions

MoxifloxacinDRUG

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

Also known as: Vigamox
VIGAMOX
besifloxacinDRUG

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

Also known as: Besivance
Besivance

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bucci Laser Vision Institute

Wilkes-Barre, Pennsylvania, 18702, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

Moxifloxacinbesifloxacin

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Frank A. Bucci Jr., MD
Organization
Bucci Laser Vision
buccivision@aol.com
570-825-5949

Study Officials

  • Frank A. Bucci, Jr., MD

    Bucci Laser Vision Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 14, 2011

First Posted

February 15, 2011

Study Start

May 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

December 22, 2020

Results First Posted

October 29, 2019

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)