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

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

MedlinePlus related topics:

Rosacea

ChemIDplus related topics:

Doxycycline Doxycycline calcium Doxycycline hyclate

U.S. FDA Resources

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

Further study details as provided by CollaGenex Pharmaceuticals:

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 ]

Estimated Enrollment:	72
Study Start Date:	November 2007
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	September 2008 (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	Recruiting
	Little Rock, Arkansas, United States, 72212
	Contact: Laurie Barber, M.D. 501-686-5150 lbarber66@yahoo.com
	Principal Investigator: Laurie Barber, M.D.

United States, Florida
	Warren Scherer, MD	Recruiting
	Naples, Florida, United States, 34103
	Contact: Warren Scherer, MD 239-261-8383

United States, Kentucky
	Kentucky Lions Eye Center	Recruiting
	Louisville, Kentucky, United States, 40202
	Contact: Xiamo Wang 502-852-3826 gnawomaix@gmail.com
	Principal Investigator: Gary Foulks, MD

United States, Missouri
	Washington University School of Medicine	Recruiting
	St. Louis, Missouri, United States, 63110
	Contact: Adina O'Neal 314-747-8014 oneala@vision.wustl.edu
	Principal Investigator: Andrew Huang, MD

United States, New York
	Marguerite McDonald, MD	Recruiting
	Lynbrook, New York, United States, 11563
	Contact: Carla Del Castillo 516-593-4026

United States, Oklahoma
	Dean McGee Eye Institute	Recruiting
	Oklahoma City, Oklahoma, United States, 73104
	Contact: Misty Youngblood 405-271-6307 misty-youngblood@dmei.org
	Principal Investigator: James Chodosh, MD

United States, Pennsylvania
	Anita Nevyas-Wallace, MD	Recruiting
	Bala Cynwyd, Pennsylvania, United States, 19004
	Contact: Anita Nevyas-Wallace, MD 610-668-2777

United States, Utah
	Tanner Clinic	Recruiting
	Layton, Utah, United States, 84041
	Contact: Amanda Tinsley 801-773-4840 ext 3741 amandaetinsley@yahoo.com
	Principal Investigator: Lance Nelson, MD

Sponsors and Collaborators

CollaGenex Pharmaceuticals

Investigators


Study Chair:	Angel Angelov, MD	CollaGenex Pharmaceuticals

More Information

Responsible Party:	CollaGenex Pharmaceuticals, Inc. ( Christopher Powala, Vice President, Drug Development and Regulatory Affairs )
Study ID Numbers:	COL-101-BLEPH-201
First Received:	November 16, 2007
Last Updated:	April 16, 2008
ClinicalTrials.gov Identifier:	NCT00560703
Health Authority:	United States: Food and Drug Administration