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| 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 |
| 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |
| Study Director: | Michael Graeber, MD | Galderma |
More Information
| 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 |
|
Antimalarials Anti-Infective Agents Anti-Bacterial Agents Antiparasitic Agents Antiprotozoal Agents Therapeutic Uses |
Eye Diseases Eyelid Diseases Blepharitis Pharmacologic Actions Doxycycline |