A Four Week, Open-Label Study of Azithromycin Ophthalmic... | NCT01220258

Studies
A Four Week, Open-Label Study of Azithromycin Ophthalmic Solution, 1% (P08641)

NCT01220258

Sponsor

Merck Sharp & Dohme LLC

Status

Terminated

Last Update Posted

Dec 16, 2013Estimated

Enrollment

29Actual

Phase

Phase 2

Conditions

Posterior Blepharoconjunctivitis

Interventions

Azithromycin ophthalmic solution, 1%

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
041-118

Official Title

A Single-Center, Open-Label Study to Characterize Eyelid Margin Erythema, Markers of Clinical Inflammation and Levels of Inflammatory Mediators in the Lid Margins and Conjunctivae of Untreated Healthy Volunteers and Subjects Diagnosed With Posterior Blepharoconjunctivitis Following Dosing With Azithromycin Ophthalmic Solution, 1% for Four Weeks

Status Module

Record Verification Date

Dec 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

Nov 2010

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Oct 12, 2010

First Submission Date that Met QC Criteria

Oct 12, 2010

First Posted Date

Oct 13, 2010Estimated

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

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2013

Last Update Posted Date

Dec 16, 2013Estimated

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

One objective of this study is to determine the levels of markers of inflammation on the eyelid margin of subjects with blepharoconjunctivitis and compare them with those of healthy volunteers. Another objective is to determine in subjects with blepharoconjunctivitis the effect of azithromycin ophthalmic solution, 1 % on markers of inflammation of lid margins and conjunctivae and on signs and symptoms of blepharoconjunctivitis.

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

29Actual

Arms/Interventions Module

Arm Groups

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

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
Change from baseline of investigator-rated scores for eyelid margin erythema		Week 4

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline of investigator-rated scores of blepharoconjunctivitis signs		Weeks 2, 4, 6, 8
Change from baseline of subject-rated scores of blepharoconjunctivitis symptoms		Weeks 2, 4, 6, 8

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have a current diagnosis of posterior blepharoconjunctivitis in both eyes

(except for healthy volunteers)

Have a Best Corrected Visual Acuity (BCVA), using corrective lenses if necessary, in both eyes of at least +0.7 LogMAR
If female, are non-pregnant or non-lactating

Exclusion Criteria:

Have anterior blepharitis
Have lid structural abnormalities
Have had penetrating intraocular surgery in the past 90 days or require

penetrating intraocular surgery during the study

Unable to withhold the use of contact lenses within 3 days prior to Visit 1

during the study

Have been diagnosed with ongoing glaucoma
Have a serious medical condition which could confound study assessments

Accepts Healthy Volunteers

Yes

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, PhD	Medical Monitor	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Baylor Eye Clinic, Alkek Eye Center of Baylor College of Medicine		Houston	Texas	77030	United States