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

Information source: Ophthalmology Consultants, Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Corneal Health; Cataract Surgery

Intervention: besivance (Drug); vigamox (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Ophthalmology Consultants, Ltd.

Official(s) and/or principal investigator(s):
Ranjan Maholtra, MD, Principal Investigator, Affiliation: Ophthalmology Associates
Joseph Gira, MD, Principal Investigator, Affiliation: Ophthalmology Consultants

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Primary outcome: corneal health

Secondary outcome: subject tolerance

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 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

Locations and Contacts

Ophthalmology Associates, St. Louis, Missouri 63131, United States

Ophthalmology Consultants, Ltd, St. Louis, Missouri 63131, United States

Additional Information

Starting date: September 2010
Last updated: October 18, 2011

Page last updated: August 23, 2015

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