A Four Week Study of Azithromycin Ophthalmic Solution, 1%... | NCT01269658

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

NCT01269658

Sponsor

Merck Sharp & Dohme LLC

Status

Terminated

Last Update Posted

Nov 21, 2013Estimated

Enrollment

40Actual

Phase

Phase 2

Conditions

Blepharitis

Interventions

Azithromycin ophthalmic solution, 1%
Vehicle

Countries

Not provided

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
P08636

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Dec 21, 2010

First Submission Date that Met QC Criteria

Jan 3, 2011

First Posted Date

Jan 4, 2011Estimated

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

Jul 6, 2011

Certification/Extension First Submitted that Passed QC Review

Jul 6, 2011

Certification/Extension First Posted Date

Jul 14, 2011Estimated

Last Update Submitted Date

Oct 29, 2013

Last Update Posted Date

Nov 21, 2013Estimated

Description Module

Brief Summary

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

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Azithromycin ophthalmic solution, 1%	Experimental		Drug: Azithromycin ophthalmic solution, 1%
Vehicle	Placebo Comparator		Drug: Vehicle

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Azithromycin ophthalmic solution, 1%	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)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Resolution of clinical signs of blepharitis		Day 28

Secondary Outcomes

Measure	Description	Time Frame
Time to first clinical resolution		Days 7, 14, 21, 28, 42, 56, 70, and 84
Mean and change from baseline for clinical signs of blepharitis		Days 7, 14, 21, 28, 42, 56, 70, and 84

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D005141	Eyelid Diseases
D005128	Eye Diseases