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

This study has been terminated.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT01269658

First received: December 21, 2010

Last updated: September 20, 2011

Last verified: September 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

December 21, 2010

Last Updated Date

September 20, 2011

Start Date ^ICMJE

December 2010

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Resolution of clinical signs of blepharitis [ Time Frame: Day 28 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01269658 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Time to first clinical resolution [ Time Frame: Days 7, 14, 21, 28, 42, 56, 70, and 84 ] [ Designated as safety issue: No ]
Mean and change from baseline for clinical signs of blepharitis [ Time Frame: Days 7, 14, 21, 28, 42, 56, 70, and 84 ] [ Designated as safety issue: No ]
Mean and change from end of dosing for clinical signs of blepharitis [ Time Frame: Days 42, 56, 70, and 84 ] [ Designated as safety issue: No ]
Response to the Blepharitis Symptoms Questionnaire (BSQ) [ Time Frame: Days 1, 7, 14, 21, 28, 42, 56, 70, and 84 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Time to first clinical resolution [ Time Frame: Days 7, 14, 21, 28, 42, 56, 70, and 84 ] [ Designated as safety issue: No ]
Mean and change from baseline for clinical signs of blepharitis [ Time Frame: Days 7, 14, 21, 28, 42, 56, 70, and 84 ] [ Designated as safety issue: No ]
Mean and change from end of dosing for clinical signs of blepharitis [ Time Frame: Days 42, 56, 70, and 84 ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Randomized, Multi-Center, Double-Masked, Vehicle-Controlled, Parallel-Group, Safety and Efficacy Study of Azithromycin Ophthalmic Solution, 1% Versus Vehicle for Four Weeks in Subjects With Blepharitis

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Blepharitis

Intervention ^ICMJE

Drug: 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)
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)

Study Arm (s)

Experimental: Azithromycin ophthalmic solution, 1%
Intervention: Drug: Azithromycin ophthalmic solution, 1%
Placebo Comparator: Vehicle
Intervention: Drug: Vehicle

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Estimated Completion Date

December 2011

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

14 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01269658

Other Study ID Numbers ^ICMJE

044-103, P08636

Has Data Monitoring Committee

Not Provided

Responsible Party

Karen Kuhn, Director, Inspire Pharmaceuticals

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Charles Johnson, MBChB

Chief Medical Officer

Information Provided By

Merck

Verification Date

September 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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