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
  Purpose

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.


Condition Intervention Phase
Corneal Health
Cataract Surgery
Drug: besivance
Drug: vigamox
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ophthalmology Consultants, Ltd.:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • subject tolerance [ Time Frame: day - 3 through day 28 ] [ Designated as safety issue: No ]
    reported adverse events


Enrollment: 60
Study Start Date: September 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: besivance
ocular antibiotic
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: vigamox
ocular antibiotic
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%

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01455233

Locations
United States, Missouri
Ophthalmology Associates
St. Louis, Missouri, United States, 63131
Ophthalmology Consultants, Ltd
St. Louis, Missouri, United States, 63131
Sponsors and Collaborators
Ophthalmology Consultants, Ltd.
Ophthalmology Associates, St Louis
Bausch & Lomb Incorporated
Investigators
Principal Investigator: Ranjan Maholtra, MD Ophthalmology Associates
Principal Investigator: Joseph Gira, MD Ophthalmology Consultants
  More Information

No publications provided

Responsible Party: Joseph Gira, M.D., Principal Investigator, Ophthalmology Consultants, Ltd.
ClinicalTrials.gov Identifier: NCT01455233     History of Changes
Other Study ID Numbers: STB-01
Study First Received: October 17, 2011
Last Updated: October 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Ophthalmology Consultants, Ltd.:
cornea
ocular antibiotic
cataract surgery

Additional relevant MeSH terms:
Cataract
Eye Diseases
Lens Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Besifloxacin
Fluoroquinolones
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Ophthalmic Solutions
Anti-Infective Agents
Antineoplastic Agents
Antitubercular Agents
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Combined
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmaceutical Solutions
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014