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| Sponsored by: |
CollaGenex Pharmaceuticals |
| Information provided by: | CollaGenex Pharmaceuticals |
| 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 |
| MedlinePlus related topics: | Rosacea |
| ChemIDplus related topics: | Doxycycline Doxycycline calcium Doxycycline hyclate |
| 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 |
|
A: Active Comparator
doxycycline
|
Drug: doxycycline
A. Oracea (doxycycline, USP) Capsules 40 mg, once per day for 84 days
|
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P: Placebo Comparator
Sugar capsule
|
Drug: placebo
Once per day for 84 days
|
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |||||
| CollaGenex Pharmaceuticals |
| 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 |
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