Trial | NCT01455233  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    60
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.
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 Started
Sep 30
2010
Primary Completion
Feb 28
2011
Study Completion
Feb 28
2011
Last Update
Oct 19
2011
Estimate

Drug besivance

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

  • Other names: besifloxacin ophthalmic suspension 0.6%

Drug vigamox

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

  • Other names: moxifloxacin hydrochloride ophthalmic solution 0.5%

besivance Active Comparator

ocular antibiotic

vigamox Active Comparator

ocular antibiotic

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:

they are breast feeding
they have a positive urine pregnancy test at screening
they are not willing to undergo a urine pregnancy test upon entering or exiting the study
they intend to become pregnant during the duration of the study; or,
they do not agree to use adequate birth control methods for the duration of the study
No Results Posted