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Treatment of Patients With Blepharitis and Facial Rosacea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00560703
First Posted: November 20, 2007
Last Update Posted: January 11, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Galderma
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

    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 ]

    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT00560703     History of Changes
Other Study ID Numbers: COL-101-BLEPH-201
First Submitted: November 16, 2007
First Posted: November 20, 2007
Results First Submitted: April 28, 2011
Results First Posted: January 11, 2012
Last Update Posted: January 11, 2012
Last Verified: December 2011

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