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OpenTrials
Completed

NCT Number: NCT00575367

Study of AzaSite Versus Vigamox in the Tears of Healthy Volunteers

The purpose of this study is to evaluate the drug concentrations of AzaSite compared to Vigamox in tears of healthy volunteers

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Key information

Conditions

Bacterial Infections Bacterial Infections and Mycoses Eye Diseases Eye Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mount Sinai School of Medicine

New York, 10029, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Have visual acuity, using corrective lenses (no contact lenses) if necessary, in both eyes of at least +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study.
  • Have normal lid anatomy.

Exclusion criteria

  • Have an abnormal biomicroscopy or ophthalmoscopy exam.
  • Have a diagnosis of dry eye disease or have experienced any of the dry eye symptoms (photophobia, foreign body sensation, itching, burning, pain, dry or grittiness) in the past thirty days.
  • Have used artificial tears in the past thirty days.
  • Have a diagnosis of on-going ocular infection or lid margin inflammation.
  • Have ever had penetrating ocular surface or intraocular surgery.
  • Have a known hypersensitivity to azithromycin, or any macrolide antibiotic or to any of the ingredients in AzaSite.
  • Have had a known hypersensitivity to Vigamox or any fluoroquinolone antibiotics or to any of the ingredients in Vigamox.
  • Have had corneal or lid abnormalities.
  • Have glaucoma, or Intra Ocular Pressure of 22 mm Hg or greater in one or both eyes.
  • Have any ocular pathology with the exception of cataracts.
  • Have a serious systemic disease or uncontrolled medical condition.
  • Have experienced symptoms of viral or allergic conjunctivitis in the past 30 days.
  • Have a history of liver or kidney disease resulting in persisting dysfunction.

Treatment and study plan

AzaSite (azithromycin ophthalmic solution)

Drug

One drop ophthalmic solution at Visit 2

Vigamox (moxifloxacin hydrochloride ophthalmic solution)

Drug

One drop ophthalmic solution at Visit 2

Primary outcomes

  1. Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration.

    Time frame: 15 minutes, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Single-Center, Open-Label, Randomized Study of the Pharmacokinetics of AzaSite Ophthalmic Solution Versus Vigamox in the Tears of Healthy Volunteers Following a Single Ocular Administration

Important dates

Study start
2008
Primary completion
2008
First posted
Dec 18, 2007
Registry last updated
Sep 22, 2011

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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