ClinicalTrials.gg
CompletedNCT01455233STB-01Updated Oct 19, 2011

2-Site Safety Study of Besivance Versus Vigamox Prophylactically in Routine Cataract Surgery

A Phase 4 interventional study of besivance and vigamox in Corneal Health and Cataract Surgery, sponsored by Ophthalmology Consultants, Ltd.. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-10-19.

Sponsored by Ophthalmology Consultants, Ltd. · Phase 4 and Interventional

Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Subjects will be assigned to receive either Besivance or Vigamox (1:1) to be administered as 1 drop in the study eye 4 times daily starting 3 days prior to cataract surgery and continuing for 7 days post-operatively.

Sixty subjects (30 from Ophthalmology Consultants and 30 from Ophthalmology Associates) of any race and either sex, requiring cataract extraction with planned implantation of a posterior chamber intraocular lens.

02

Conditions studied

  • Corneal Health
  • Cataract Surgery

Browse trials for

Keywords

  • cornea
  • ocular antibiotic
  • cataract surgery
03

In context

Corneal Diseases

136 studies on the registry are indexed under Corneal Diseases; 44 are open to participants now.

This study's enrollment of 60 is above the median of 32 across 81 interventional studies indexed under Corneal Diseases.

Browse Corneal Diseases studies →

Lead sponsor

This is the only study on the registry with Ophthalmology Consultants, Ltd. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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:

    1. they are breast feeding
    2. they have a positive urine pregnancy test at screening
    3. they are not willing to undergo a urine pregnancy test upon entering or exiting the study
    4. they intend to become pregnant during the duration of the study; or,
    5. they do not agree to use adequate birth control methods for the duration of the study
05

Study design

Phase
Phase 4
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    besivance

    ocular antibiotic

    Drug: vigamox

  • Active comparator
    vigamox

    ocular antibiotic

    Drug: besivance

Interventions

  • 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%

  • 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%

06

What researchers measure

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)

    Time frame: through day 28 post op

Secondary outcomes

  1. subject tolerance

    reported adverse events

    Time frame: day - 3 through day 28

07

Study locations

2 sites
  • Ophthalmology Associates
    St Louis, Missouri 63131, United States
  • Ophthalmology Consultants, Ltd
    St Louis, Missouri 63131, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01455233
Lead sponsor
Ophthalmology Consultants, Ltd.
Collaborators
Ophthalmology Associates, St Louis, Bausch & Lomb Incorporated
Responsible party
Joseph Gira, M.D. (Principal Investigator, Ophthalmology Consultants, Ltd.) — Principal investigator
First posted
Oct 19, 2011
Start date
Sep 2010
Primary completion
Feb 2011
Completion
Feb 2011
Last update
Oct 19, 2011

Study contacts

Ranjan Maholtra, MD
principal investigator · Ophthalmology Associates
Joseph Gira, MD
principal investigator · Ophthalmology Consultants

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Besifloxacin · Moxifloxacin

Start the discussion