Safety and Efficacy Pilot Study of AzaSite (Azithromycin) in Subjects With Blepharitis

NCT ID: NCT00629590

Last Updated: 2011-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 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 safety and efficacy of AzaSite ophthalmic solution, 1% on signs and symptoms of blepharitis.

Detailed Description

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Conditions

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Blepharitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

AzaSiteĀ®

Intervention Type DRUG

ophthalmic solution; 1 drop in each eye BID for two days, then 1 drop in each eye QD for \~12 days

2

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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AzaSiteĀ®

ophthalmic solution; 1 drop in each eye BID for two days, then 1 drop in each eye QD for \~12 days

Intervention Type DRUG

Other Intervention Names

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AzaSite

Eligibility Criteria

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Inclusion Criteria

* diagnosis of moderate to severe chronic posterior blepharitis
* if female of childbearing potential, are non-pregnant and non-lactating

Exclusion Criteria

* had ocular surface surgery (LASIK, refractive, etc.) within the past year
* unwilling to discontinue use of contact lenses during the study
* have glaucoma
* unable or unwilling to withhold the use of lid scrubs during the study
* have a serious systemic disease or uncontrolled medical condition that in the judgment of the investigator could confound study assessments or limit compliance
* currently using any preserved topical ocular medications (with the exception of unpreserved tear substitutes) at the time of entry into the study or during study participation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Sponsor

Principal Investigators

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Reza Haque

Role: STUDY_DIRECTOR

works for Sponsor

Locations

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South Shore Eye Care

Wantagh, New York, United States

Site Status

Countries

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United States

Other Identifiers

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P08649

Identifier Type: -

Identifier Source: secondary_id

041-106

Identifier Type: -

Identifier Source: org_study_id