Treatment of Patients With Blepharitis and Facial Rosacea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT00560703
First received: November 16, 2007
Last updated: December 9, 2011
Last verified: December 2011
  Purpose

To determine the safety and efficacy of sub-antimicrobial dose COL-101 in the treatment of patients who have both blepharitis and facial rosacea


Condition Intervention Phase
Blepharitis
Meibomianitis
Dry Eye
Drug: COL-101 (doxycycline, USP) capsules
Drug: placebo
Phase 2

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
Official Title: Efficacy and Safety of COL-101 for the Treatment of Blepharitis in Patients With Facial Rosacea

Resource links provided by NLM:


Further study details as provided by Galderma:

Primary Outcome Measures:
  • Change in Bulbar Conjunctival Hyperemia [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]

    Bulbar conjunctival hyperemia will be assessed using an ordered categorical value ranging from 0 (Clear) to 4 (Severe). Hyperemia is graded on the following scale and half scores are acceptable:

    None (0) = normal Mild (1) = slight localized injection Moderate (2) = pink color Severe (3) = red color Very Severe (4) = marked dark redness


  • Change in Ocular Surface Disease Index (OSDI) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]

    OSDI is calculated based following formula using 12-question Ocular Surface Disease questionnaire (with each question scored 0-4):

    OSDI = (D/E)x25, where D = Sum of all scores for questions answered E = Total number of questions answered (not including questions answered NA)

    Range of OSDI is 0 to 100 (higher score indicates worse condition).



Enrollment: 70
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
Active Comparator: COL-101 (doxycycline, USP) capsules
COL-101
Drug: COL-101 (doxycycline, USP) capsules
40mg, once per day for 84 days
Placebo Comparator: Placebo
Sugar capsule
Drug: placebo
sugar capsule

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560703

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
Sponsors and Collaborators
Galderma
Investigators
Study Director: Michael Graeber, MD Galderma
  More Information

No publications provided

Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT00560703     History of Changes
Other Study ID Numbers: COL-101-BLEPH-201
Study First Received: November 16, 2007
Results First Received: April 28, 2011
Last Updated: December 9, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Blepharitis
Rosacea
Eyelid Diseases
Eye Diseases
Skin Diseases
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on August 20, 2014