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

Purpose

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.

Condition	Intervention	Phase
Blepharitis	Drug: Azithromycin ophthalmic solution, 1% Drug: Vehicle	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Azithromycin Azithromycin dihydrate Azithromycin monohydrate

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	40
Study Start Date:	December 2010
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Azithromycin ophthalmic solution, 1%	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)
Placebo Comparator: Vehicle	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)

Eligibility

Ages Eligible for Study:	14 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01269658

Locations

United States, California
Sall Research Medical Center, Inc.
Artesia, California, United States, 90701
Martel Eye Medical Group
Rancho Cordova, California, United States, 95670
Wolstan & Goldberg Eye Associates
Torrence, California, United States, 90505
United States, Florida
Hernando Eye Institute
Brooksville, Florida, United States, 34613
Marvin E. Greenberg, MD, LLC
Tamarac, Florida, United States, 33321
International Research Center
Tampa, Florida, United States, 33603
United States, Illinois
Wohl Eye Center
Bloomingdale, Illinois, United States, 60108
United States, Kentucky
Kentucky Center for Vision D.B.A. Koffler Vision Group
Lexington, Kentucky, United States, 40509
John-Kenyon American Eye Institute
Louisville, Kentucky, United States, 40207
United States, Missouri
Tauber Eye Center
Kansas City, Missouri, United States, 64111
Opthalmology Associates
St. Louis, Missouri, United States, 63131
Comprehensive Eye Care
Washington, Missouri, United States, 63090
Comprehensive Eye Care, Ltd.
Washington, Missouri, United States, 63090
United States, Nevada
Abrams Eye Institute
Las Vegas, Nevada, United States, 89148
Douglas K. Devries, OD
Sparks, Nevada, United States, 89431
United States, Ohio
Abrams Eye Center
Cleveland, Ohio, United States, 44115
United States, Oregon
Roseburg Research Associates, LLC
Roseburg, Oregon, United States, 97471
United States, Tennessee
University Eye Surgeons
Maryville, Tennessee, United States, 37803
United States, Texas
The Cataract & Glaucoma Center
El Paso, Texas, United States, 79902
R and R Eye Research, LLC
San Antonio, Texas, United States, 78229
Eye Clinics of South Texas
San Antonio, Texas, United States, 78209

Sponsors and Collaborators

Merck

Investigators

Study Chair:

Charles Johnson, MBChB

Chief Medical Officer

More Information

No publications provided

Responsible Party:	Karen Kuhn, Director, Inspire Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01269658 History of Changes
Other Study ID Numbers:	044-103, P08636
Study First Received:	December 21, 2010
Last Updated:	May 22, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Blepharitis
Eyelid Diseases
Eye Diseases
Azithromycin

Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013