Treatment of Patients With Blepharitis and Facial Rosacea
To determine the safety and efficacy of sub-antimicrobial dose COL-101 in the treatment of patients who have both blepharitis and facial...
Brief Summary
Official Title: “Efficacy and Safety of COL-101 for the Treatment of Blepharitis in Patients With Facial Rosacea”
To determine the safety and efficacy of sub-antimicrobial dose COL-101 in the treatment of patients who have both blepharitis and facial rosacea
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
- Study Primary Completion Date: May 2009
Intervention(s) in this Clinical Trial
- Drug: COL-101 (doxycycline, USP) capsules
- 40mg, once per day for 84 days
- Drug: placebo
- sugar capsule
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: COL-101 (doxycycline, USP) capsules
- COL-101
- Placebo Comparator: Placebo
- Sugar capsule
Outcome Measures for this Clinical Trial
Primary Measures
- Change in Bulbar Conjunctival Hyperemia
- Time Frame: Baseline to Week 12
Safety Issue?: No
- Time Frame: Baseline to Week 12
- Change in Ocular Surface Disease Index (OSDI)
- Time Frame: Baseline to Week 12
Safety Issue?: No
- Time Frame: Baseline to Week 12
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- blepharitis
- facial rosacea
Exclusion Criteria:
- pregnant or nursing women
- allergy to tetracyclines
- recent eye surgery
- past or current use of isotretinoin
- patients who are achlorhydric
- patients who have had gastric by-pass surgery
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Galderma Industry
Overall Clinical Trial Officials and Contacts
Michael Graeber, MD Study Director Galderma
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00560703
Study ID Number: COL-101-BLEPH-201
ClinicalTrials.gov Identifier: NCT00560703
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00560703
