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

Ophthalmology Consultants, Ltd.

Status and phase

Completed

Phase 4

Conditions

Cataract Surgery

Corneal Health

Treatments

Drug: vigamox

Drug: besivance

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01455233

STB-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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