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Study of AzaSite (Azithromycin) Versus Vigamox in the Conjunctiva of Healthy Volunteers

NCT ID: NCT00564447

Last Updated: 2011-09-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Brief Summary

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The purpose of this study is to evaluate the drug concentrations of AzaSite™ compared to Vigamox at various time points in conjunctiva tissue 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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Azithromycin-30 minutes Post dose

Group Type EXPERIMENTAL

Azithromycin

Intervention Type DRUG

azithromycin topical solution 1% given as a single drop in a single eye

Azithromycin-2 hours post dose

Group Type EXPERIMENTAL

Azithromycin

Intervention Type DRUG

azithromycin topical solution 1% given as a single drop in a single eye

Azithromycin-12 hours post dose

Group Type EXPERIMENTAL

Azithromycin

Intervention Type DRUG

azithromycin topical solution 1% given as a single drop in a single eye

Azithromycin-24 hours post dose

Group Type EXPERIMENTAL

Azithromycin

Intervention Type DRUG

azithromycin topical solution 1% given as a single drop in a single eye

Moxifloxacin-30 minutes post dose

Group Type EXPERIMENTAL

Moxifloxacin

Intervention Type DRUG

Moxifloxacin topical solution given as a single drop in a single eye

Moxifloxacin-2 hours post dose

Group Type EXPERIMENTAL

Moxifloxacin

Intervention Type DRUG

Moxifloxacin topical solution given as a single drop in a single eye

Moxifloxacin-12 hours post dose

Group Type EXPERIMENTAL

Moxifloxacin

Intervention Type DRUG

Moxifloxacin topical solution given as a single drop in a single eye

Moxafloxacin-24 hours post dose

Group Type EXPERIMENTAL

Moxifloxacin

Intervention Type DRUG

Moxifloxacin topical solution given as a single drop in a single eye

Interventions

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Azithromycin

azithromycin topical solution 1% given as a single drop in a single eye

Intervention Type DRUG

Moxifloxacin

Moxifloxacin topical solution given as a single drop in a single eye

Intervention Type DRUG

Other Intervention Names

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AzaSite Vigamox

Eligibility Criteria

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Inclusion Criteria

* Have best corrected visual acuity of 0.60 logMAR or better in each eye as measured using Early Treatment of Diabetic Retinopathy Study chart

Exclusion Criteria

* Have a known allergy and/or sensitivity to the test article(s) or its components or any therapies associated with the trial
* Have active signs or symptoms of any clinically significant ocular disorder (other than refractive disorders)
* Have a known bleeding disorder or history of bleeding complications after surgical or dental procedures
* Take aspirin, or take any other blood thinners or anti-coagulants (e.g. warfarin) including prescription, over the counter, or homeopathic therapies
* Have undergone any ocular surgical intervention within 3 months prior to Visit 1 or anticipate having ocular surgery during the study
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

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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Torkildsen G, O'Brien TP. Conjunctival tissue pharmacokinetic properties of topical azithromycin 1% and moxifloxacin 0.5% ophthalmic solutions: a single-dose, randomized, open-label, active-controlled trial in healthy adult volunteers. Clin Ther. 2008 Nov;30(11):2005-14. doi: 10.1016/j.clinthera.2008.10.020.

Reference Type DERIVED
PMID: 19108788 (View on PubMed)

Other Identifiers

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P08654

Identifier Type: -

Identifier Source: secondary_id

041-102

Identifier Type: -

Identifier Source: org_study_id