MedDataX Logo

Safety and Efficacy Study of AzaSite® in Subjects With Blepharitis

NCT ID: NCT00629941

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the safety and efficacy of AzaSite® ophthalmic solution, 1% on signs \& symptoms of blepharitis and tear cytokine and eyelid bacterial load levels

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Blepharitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

AzaSite®

Intervention Type DRUG

Ophthalmic solution; 1 drop in each eye BID for two days, then 1 drop in each eye QD for \~26 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AzaSite®

Ophthalmic solution; 1 drop in each eye BID for two days, then 1 drop in each eye QD for \~26 days

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosis of moderate to severe chronic 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

Meet the organizations funding or collaborating on the study and learn about their roles.

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

sponsor

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Reza Haque, MD

Role: STUDY_DIRECTOR

Sponsor GmbH

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Central Maine Eye Care

Lewiston, Maine, United States

Site Status

Ophthalmic Research Associates

Andover, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P08652

Identifier Type: -

Identifier Source: secondary_id

041-104

Identifier Type: -

Identifier Source: org_study_id