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Study of AzaSite Versus Vigamox in the Tears of Healthy Volunteers

NCT ID: NCT00575367

Last Updated: 2011-09-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Brief Summary

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

Detailed Description

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Conditions

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Bacterial Infections Eye Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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AzaSite

Group Type ACTIVE_COMPARATOR

AzaSite (azithromycin ophthalmic solution)

Intervention Type DRUG

One drop ophthalmic solution at Visit 2

Vigamox

Group Type ACTIVE_COMPARATOR

Vigamox (moxifloxacin hydrochloride ophthalmic solution)

Intervention Type DRUG

One drop ophthalmic solution at Visit 2

Interventions

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AzaSite (azithromycin ophthalmic solution)

One drop ophthalmic solution at Visit 2

Intervention Type DRUG

Vigamox (moxifloxacin hydrochloride ophthalmic solution)

One drop ophthalmic solution at Visit 2

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Inspire Pharmaceuticals, Inc.

Principal Investigators

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Reza Haque, MD

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Mount Sinai School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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P08653

Identifier Type: -

Identifier Source: secondary_id

041-101

Identifier Type: -

Identifier Source: org_study_id