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Sponsored by: |
CollaGenex Pharmaceuticals |
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Information provided by: | CollaGenex Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00560703 |
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 |
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 |
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A: Active Comparator
doxycycline
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Drug: doxycycline
A. Oracea (doxycycline, USP) Capsules 40 mg, once per day for 84 days
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P: Placebo Comparator
Sugar capsule
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Drug: placebo
Once per day for 84 days
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Chair: | Angel Angelov, MD | CollaGenex Pharmaceuticals |
Responsible Party: | CollaGenex Pharmaceuticals, Inc. ( Christopher Powala, Vice President, Drug Development and Regulatory Affairs ) |
Study ID Numbers: | COL-101-BLEPH-201 |
Study First Received: | November 16, 2007 |
Last Updated: | April 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00560703 |
Health Authority: | United States: Food and Drug Administration |
Rosacea Facies Eye Diseases Blepharitis Doxycycline |
Antimalarials Anti-Infective Agents Anti-Bacterial Agents Antiparasitic Agents |
Antiprotozoal Agents Therapeutic Uses Eyelid Diseases Pharmacologic Actions |