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 doxycycline in the treatment of patients who have both blepharitis and facial rosacea

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2008

Intervention(s) in this Clinical Trial

• Drug: doxycycline
  • A. Oracea (doxycycline, USP) Capsules 40 mg, once per day for 84 days
• Drug: placebo
  • Once per day for 84 days

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
  • doxycycline
• Placebo Comparator: P
  • Sugar capsule

Primary Measures

• Change in Ocular Surface Disease Index Change in bulbar conjunctival hyperemia
  • Time Frame: Baseline to end of study
    Safety Issue?: No

Secondary 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
    Safety Issue?: No

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?: Accepts Healthy Volunteers

Lead Sponsor: CollaGenex Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Angel Angelov, MD Study Chair CollaGenex Pharmaceuticals  

Information obtained from ClinicalTrials.gov on August 29, 2008

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