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

Cataract Surgery Clinical Trial

— STB-01  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01455233
• Other study ID #: STB-01
• Status: Completed
• Phase: Phase 4
• First received: October 17, 2011
• Last updated: October 18, 2011
• Start date: September 2010
• Est. completion date: February 2011

Study information

• Verified date: December 2010
• Source: Ophthalmology Consultants, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Cataract Surgery
• Corneal Health

Intervention

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

Locations

Country	Name	City	State
United States	Ophthalmology Associates	St. Louis	Missouri
United States	Ophthalmology Consultants, Ltd	St. Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Ophthalmology Consultants, Ltd.	Bausch & Lomb Incorporated, Ophthalmology Associates, St Louis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	subject tolerance	reported adverse events	day - 3 through day 28