Clinical trial NCT01455233: 2-Site Safety Study of Besivance Versus Vigamox Prophylactically in Routine Cataract Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Corneal Health
Cataract Surgery
Keywords: cornea
ocular antibiotic
cataract surgery
Lead sponsor: Ophthalmology Consultants, Ltd.
Sponsor class: OTHER
Collaborators: name: Ophthalmology Associates, St Louis
name: Bausch & Lomb Incorporated
First posted: 2011-10-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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

Primary outcomes:
measure: corneal health
timeFrame: through day 28 post op
Secondary outcomes:
measure: subject tolerance
timeFrame: day - 3 through day 28
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: St. Louis
country: United States
facility: Ophthalmology Consultants, Ltd
state: Missouri
Study officials:
affiliation: Ophthalmology Associates
name: Ranjan Maholtra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ophthalmology Consultants
name: Joseph Gira, MD
role: PRINCIPAL_INVESTIGATOR
References: