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

Phase 4

Completed

• Conditions: Corneal Health; Cataract Surgery
• Interventions: Drug: vigamox; Drug: besivance

• Registration Number: NCT01455233
• Lead Sponsor: Ophthalmology Consultants, Ltd.

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.

Study Timeline

• Study Start: 2010-09
• Status Verified: 2010-12
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Study First Submitted: 2011-10-17
• Study First Submitted QC: 2011-10-18
• Last Update Submitted: 2011-10-18
• Study First Posted: 2011-10-19
• Last Update Posted: 2011-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
besivance	vigamox	ocular antibiotic
vigamox	besivance	ocular antibiotic

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
subject tolerance	day - 3 through day 28	reported adverse events

Trial Locations

Locations (2)

Ophthalmology Associates; 🇺🇸 St. Louis, Missouri, United States

Ophthalmology Consultants, Ltd; 🇺🇸 St. Louis, Missouri, United States