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

NCT ID: NCT01455233

Last Updated: 2011-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-02-28

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.

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.

Conditions

Corneal Health; Cataract Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

besivance

ocular antibiotic

Group Type: ACTIVE_COMPARATOR

vigamox

Intervention Type: DRUG

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

vigamox

ocular antibiotic

Group Type: ACTIVE_COMPARATOR

besivance

Intervention Type: DRUG

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

Interventions

besivance

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

Intervention Type: DRUG

vigamox

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

Intervention Type: DRUG

Other Intervention Names

besifloxacin ophthalmic suspension 0.6%; moxifloxacin hydrochloride ophthalmic solution 0.5%

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ophthalmology Associates, St Louis

OTHER

Sponsor Role: collaborator

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: collaborator

Ophthalmology Consultants, Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Joseph Gira, M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ranjan Maholtra, MD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmology Associates

Joseph Gira, MD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmology Consultants

Locations

Ophthalmology Associates

St Louis, Missouri, United States

Ophthalmology Consultants, Ltd

St Louis, Missouri, United States

Countries

United States

Other Identifiers

STB-01

Identifier Type: -

Identifier Source: org_study_id