Safety and Efficacy Pilot Study of AzaSite® for Four Week... | NCT00656539

Studies
Safety and Efficacy Pilot Study of AzaSite® for Four Weeks in Subjects With Blepharitis

NCT00656539

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Sep 26, 2011Estimated

Enrollment

20Estimated

Phase

Phase 4

Conditions

Blepharitis

Interventions

AzaSite®

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
P08647

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Nov 2008Actual

Completion Date

Not provided

First Submitted Date

Apr 7, 2008

First Submission Date that Met QC Criteria

Apr 7, 2008

First Posted Date

Apr 11, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Mar 24, 2009

Certification/Extension First Submitted that Passed QC Review

May 4, 2009

Certification/Extension First Posted Date

Nov 17, 2009Estimated

Last Update Submitted Date

Sep 20, 2011

Last Update Posted Date

Sep 26, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	AzaSite®	Drug: AzaSite®
2	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AzaSite®	Drug	Ophthalmic solution; 1 drop in each eye BID for two days, then 1 drop in each eye QD for ~26 days	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in clinical signs and symptoms associated with blepharitis		4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Standard ocular safety assessments		4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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, pterygium) within the past year
unwilling to discontinue use of contact lenses during the study
have glaucoma
unable or unwilling to withhold the use of eyelid 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Reza Haque, MD	Medical Monitor	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ophthalmic Consultants of Long Island		Lynbrook	New York	11563	United States

Condition Browse Module

MeSH Terms

ID	Term
D001762	Blepharitis

Ancestor Terms

ID	Term
D005141	Eyelid Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017963	Azithromycin

Ancestor Terms

ID	Term
D004917	Erythromycin
D018942	Macrolides
D061065	Polyketides
D007783	Lactones
D009930

Browse Leaves

Not provided

Browse Branches

Not provided