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OpenTrials
Completed

NCT Number: NCT01296542

A Comparison of Prophylactic Antibacterial Efficacy of Besivance vs. VIGAMOX Prior to Cataract Surgery

To compare antibacterial efficacy of Besivance versus VIGAMOX for decreasing bacteria of the conjunctiva and lid margins in cataract patients prior to surgery after both 1 hour and 3 days of treatment.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bucci Laser Vision Institute

Wilkes-Barre, Pennsylvania, 18702, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Man or woman 18 years of age or older.
  • Physically capable of instilling eye drop or have an appropriate person available to assist in administration of eye drops 4 times a day.
  • Scheduled for phacoemulsification with intraocular lens (IOL) implantation for the treatment of cataract.
  • Meet the American Society of Anesthesiology (ASA) physical status I, II, or III and be medically cleared for surgery.
  • Willing to adhere to the prohibitions and restrictions specified in this protocol.
  • Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion criteria

  • Known allergy or contraindication to the test article(s) or their components.
  • Presence of any abnormality or significant illness in the eye that in the investigator's opinion could affect the subject's health or the study parameters.
  • Presence of an active ocular infection (bacterial, viral or fungal), or positive history of ocular herpetic infection.
  • History of any significant illness that could be expected to interfere with the study parameters. Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study.
  • Use of disallowed therapies (systemic or topical):
  • Fluoroquinolone anti-infective agents (systemic or topical) within 1 week of Visit 1 or anytime after Visit 1 for the duration of the study.
  • Use of contact lenses for one week prior to the study and for the duration of the study.
  • Received an experimental drug or used an experimental medical device within 21 days before the planned start of treatment.

Treatment and study plan

Moxifloxacin Ophthalmic

Drug

Besifloxacin Ophthalmic

Drug

Primary outcomes

  1. Number of Subjects With a Change in Bacterial Colonization of Lid and Conjunctival Cultures After 3 Days

    Time frame: Following 3 days of antibiotic drops topically instilled

    Lid and Conjunctival cultures will be taken to measure bacterial colonization.

Sponsors and collaborators

Lead sponsor

Bucci Laser Vision Institute

Other

Registry information

Official study title

A Comparison of Prophylactic Antibacterial Efficacy of Besivance Versus VIGAMOX Administered for Three Days and One Hour Prior to Phacoemulsification

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 15, 2011
Registry last updated
Dec 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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