NCT01455233

Brief Summary

The purpose of this study is to demonstrate that Besivance is equal to Vigamox in safety and tolerance when used prophylactically in subjects undergoing routine cataract surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

September 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2011

Completed
Last Updated

October 19, 2011

Status Verified

December 1, 2010

Enrollment Period

5 months

First QC Date

October 17, 2011

Last Update Submit

October 18, 2011

Conditions

Corneal HealthCataract Surgery

Keywords

corneaocular antibioticcataract surgery

Outcome Measures

Primary Outcomes (1)

  • corneal health

    Endothelial Cell Count (day 7, day 28) Pachymetry (day 7, day 28) Corneal Fluorescein Staining (day 7, day 28) Biomicroscopy (day 1, day 7, day 28)

    through day 28 post op

Secondary Outcomes (1)

  • subject tolerance

    day - 3 through day 28

Study Arms (2)

besivance

ACTIVE COMPARATOR

ocular antibiotic

Drug: vigamox

vigamox

ACTIVE COMPARATOR

ocular antibiotic

Drug: besivance

Interventions

besivanceDRUG

topical ocular antibiotic, 1 drop in study eye QID starting 3 days prior and for 7 days following cataract surgery

Also known as: besifloxacin ophthalmic suspension 0.6%
vigamox
vigamoxDRUG

topical ocular antibiotic, 1 drop in study eye QID for 3 days prior and for 7 days following cataract surgery

Also known as: moxifloxacin hydrochloride ophthalmic solution 0.5%
besivance

Eligibility Criteria

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

You may qualify if:

  • Men or woen of any race, 18 years or older who have a cataract, and are planning to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens
  • Study eye of patients who, in the opinion of the investigator, will experience improvement in visual acuity following surgery
  • Patients who are able to understand and sign an informed consent form that has been approved by an IRB

You may not qualify if:

  • Planned multiple procedures during cataract/IOL implantation surgery. Note: A planned limbal relaxing incision may be performed for the correction of astigmatism
  • Use of topical ocular or systemic antibiotics within 14 days prior to surgery and through study exit
  • History of or Fuch's Corneal Endothelial Dystrophy
  • Any ocular inflammation (aqueous cells or flare greater than Grade 0) or ocular pain in the study eye that is present during the baseline visit.
  • Recent (within 6 months) ocular trama to the operative eye (this includes intraocular surgery)
  • A history of chronic or recurrent inflammatory eye disease (eg, iritis, scleritis, uveitis, iridocyclitis, rubeosis iridis) in the operative eye
  • Currently diagnosed uncontrolled glaucoma in the operative eye
  • Congenital ocular anomaly (eg, aniridia, congenital cataract) in the operative eye
  • A visually nonfunctional fellow eye defined as a best corrected visual acuity \</= 35 ETDRS letters (20/200 Snellen equivalent) or worse
  • Participation in any other investigational drug or device study within 30 days before cataract surgery
  • Known or suspected allergy or hypersensitivity to any component of either test article
  • Women of childbearing potential (those who are not surgically sterilized or post menopausal) may not participate in the study if any of the following conditions exist:
  • they are breast feeding
  • they have a positive urine pregnancy test at screening
  • they are not willing to undergo a urine pregnancy test upon entering or exiting the study
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ophthalmology Associates

St Louis, Missouri, 63131, United States

Location

Ophthalmology Consultants, Ltd

St Louis, Missouri, 63131, United States

Location

MeSH Terms

Conditions

Corneal Diseases

Interventions

besifloxacinMoxifloxacin

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Ranjan Maholtra, MD

    Ophthalmology Associates

    PRINCIPAL INVESTIGATOR

  • Joseph Gira, MD

    Ophthalmology Consultants

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 17, 2011

First Posted

October 19, 2011

Study Start

September 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

October 19, 2011

Record last verified: 2010-12

Locations

US(2)