Corneal Health, Cataract Surgery
Conditions
Keywords
cornea, ocular antibiotic, cataract surgery
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.
Interventions
Sponsors
Ophthalmology Associates, St Louis
Bausch & Lomb Incorporated
Ophthalmology Consultants, Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| corneal health | through day 28 post op | 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
| Measure | Time frame | Description |
|---|---|---|
| subject tolerance | day - 3 through day 28 | reported adverse events |
Countries
United States
Outcome results
None listed