Treatment of Patients With Blepharitis and Facial Rosacea - Full Text View

Sponsor:	Galderma
Information provided by:	Galderma
ClinicalTrials.gov Identifier:	NCT00560703

Purpose

To determine the safety and efficacy of sub-antimicrobial dose doxycycline in the treatment of patients who have both blepharitis and facial rosacea

Condition	Intervention	Phase
Blepharitis Meibomianitis Dry Eye	Drug: doxycycline Drug: placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of COL-101 for the Treatment of Blepharitis in Patients With Facial Rosacea

Resource links provided by NLM:

MedlinePlus related topics: Rosacea

Drug Information available for: Doxycycline Doxycycline hyclate Doxycycline calcium

Further study details as provided by Galderma:

Primary Outcome Measures:

Change in Ocular Surface Disease Index Change in bulbar conjunctival hyperemia [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in Schirmer tear test at each study visit Change in tear break-up time at each study visit Change in meibum character/fluidity at each study visit Change in meibomian gland inspissation at each study visit [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]

Enrollment:	80
Study Start Date:	November 2007
Study Completion Date:	July 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator doxycycline	Drug: doxycycline A. Oracea (doxycycline, USP) Capsules 40 mg, once per day for 84 days
P: Placebo Comparator Sugar capsule	Drug: placebo Once per day for 84 days

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560703

Locations

United States, Arkansas
Pleasant Valley Ophthalmology
Little Rock, Arkansas, United States, 72212
United States, Florida
Warren Scherer, MD
Naples, Florida, United States, 34103
United States, Kentucky
Kentucky Lions Eye Center
Louisville, Kentucky, United States, 40202
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New York
Marguerite McDonald, MD
Lynbrook, New York, United States, 11563
United States, Oklahoma
Dean McGee Eye Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Anita Nevyas-Wallace, MD
Bala Cynwyd, Pennsylvania, United States, 19004
United States, Utah
Tanner Clinic
Layton, Utah, United States, 84041

Sponsors and Collaborators

Galderma

Investigators

Study Director:

Michael Graeber, MD

Galderma

More Information

No publications provided

Responsible Party:	Galderma ( Michael Graeber, Head of Global Clinical Project Management & US Development )
Study ID Numbers:	COL-101-BLEPH-201
Study First Received:	November 16, 2007
Last Updated:	September 30, 2009
ClinicalTrials.gov Identifier:	NCT00560703 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Antimalarials
Anti-Infective Agents
Anti-Bacterial Agents
Antiparasitic Agents
Antiprotozoal Agents
Therapeutic Uses

Eye Diseases
Eyelid Diseases
Blepharitis
Pharmacologic Actions
Doxycycline

ClinicalTrials.gov processed this record on February 08, 2010