2-Site Safety Study of Besivance Versus Vigamox Prophylactically in Routine Cataract Surgery (STB-01)

This study has been completed.
Sponsor:
Collaborators:
Ophthalmology Associates, St Louis
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Joseph Gira, M.D., Ophthalmology Consultants, Ltd.
ClinicalTrials.gov Identifier:
NCT01455233
First received: October 17, 2011
Last updated: October 18, 2011
Last verified: December 2010

October 17, 2011
October 18, 2011
September 2010
February 2011   (final data collection date for primary outcome measure)
corneal health [ Time Frame: through day 28 post op ] [ Designated as safety issue: Yes ]
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)
Same as current
Complete list of historical versions of study NCT01455233 on ClinicalTrials.gov Archive Site
subject tolerance [ Time Frame: day - 3 through day 28 ] [ Designated as safety issue: No ]
reported adverse events
Same as current
Not Provided
Not Provided
 
2-Site Safety Study of Besivance Versus Vigamox Prophylactically in Routine Cataract Surgery
Phase IV Study: A Prospective Two-Site Study to Evaluate the Safety and Tolerance of Besivance Versus Vigamox Prophylactically Pre and Post Operatively in Subjects Undergoing Routine Cataract Surgery

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
  • Corneal Health
  • Cataract Surgery
  • Drug: besivance
    topical ocular antibiotic, 1 drop in study eye QID starting 3 days prior and for 7 days following cataract surgery
    Other Name: besifloxacin ophthalmic suspension 0.6%
  • Drug: vigamox
    topical ocular antibiotic, 1 drop in study eye QID for 3 days prior and for 7 days following cataract surgery
    Other Name: moxifloxacin hydrochloride ophthalmic solution 0.5%
  • Active Comparator: besivance
    ocular antibiotic
    Intervention: Drug: vigamox
  • Active Comparator: vigamox
    ocular antibiotic
    Intervention: Drug: besivance
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
February 2011
February 2011   (final data collection date for primary outcome measure)

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:

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01455233
STB-01
Yes
Joseph Gira, M.D., Ophthalmology Consultants, Ltd.
Ophthalmology Consultants, Ltd.
  • Ophthalmology Associates, St Louis
  • Bausch & Lomb Incorporated
Principal Investigator: Ranjan Maholtra, MD Ophthalmology Associates
Principal Investigator: Joseph Gira, MD Ophthalmology Consultants
Ophthalmology Consultants, Ltd.
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP