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A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Vehicle in Subjects With Blepharitis (P08636)

NCT ID: NCT01269658

Last Updated: 2013-11-21

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-06-30

Brief Summary

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The purpose of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% versus vehicle over a four-week treatment period in treating the signs and symptoms of subjects with blepharitis and to evaluate the clinical course of the condition under study.

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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Azithromycin ophthalmic solution, 1%

Group Type EXPERIMENTAL

Azithromycin ophthalmic solution, 1%

Intervention Type DRUG

1 drop twice daily (BID) for the first 2 days and then 1 drop once daily (QD) for the remainder of treatment period (approximately 28 days total)

Vehicle

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

1 drop twice daily (BID) for the first 2 days and then 1 drop once daily (QD) for the remainder of treatment period (approximately 28 days total)

Interventions

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Azithromycin ophthalmic solution, 1%

1 drop twice daily (BID) for the first 2 days and then 1 drop once daily (QD) for the remainder of treatment period (approximately 28 days total)

Intervention Type DRUG

Vehicle

1 drop twice daily (BID) for the first 2 days and then 1 drop once daily (QD) for the remainder of treatment period (approximately 28 days total)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have a current diagnosis of blepharitis
* Have a best corrected visual acuity (BCVA), using corrective lenses if

necessary, in both eyes of at least +0.7

* If female, are non-pregnant or non-lactating

Exclusion Criteria

* Have a concurrent acute hordeolum (stye) or chalazion
* Have inflammation of the ocular surface
* Have used artificial tears within 48 hours prior to Visit 1 or anticipate

using during the study

* Have had ocular surgery in the past 90 days or will require it during the

study

* Unable to withhold the use of contact lenses during the study
* Have a known hypersensitivity to azithromycin, erythromycin, any other

macrolide antibiotic, or any of the other ingredients in the study

medication

* Have been diagnosed with ongoing glaucoma
* Unable to withhold the use of ocular cosmetic products within 48 hours

prior to Visit 1 and throughout the study

* Have a serious medical condition which could confound study assessments
Minimum Eligible Age

14 Years

Maximum Eligible Age

70 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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Responsibility Role SPONSOR

Principal Investigators

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Charles Johnson, MBChB

Role: STUDY_CHAIR

Chief Medical Officer

Countries

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United States

Other Identifiers

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P08636

Identifier Type: -

Identifier Source: secondary_id

P08636

Identifier Type: -

Identifier Source: org_study_id