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Treatment of Patients With Blepharitis and Facial Rosacea

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. Identifier: NCT00560703
Recruitment Status : Completed
First Posted : November 20, 2007
Results First Posted : January 11, 2012
Last Update Posted : February 18, 2021
Information provided by (Responsible Party):
Galderma R&D

Brief Summary:
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 or disease Intervention/treatment Phase
Blepharitis Meibomianitis Dry Eye Drug: COL-101 (doxycycline, USP) capsules Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
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
Study Start Date : November 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rosacea
MedlinePlus related topics: Rosacea

Arm Intervention/treatment
Active Comparator: COL-101 (doxycycline, USP) capsules
Drug: COL-101 (doxycycline, USP) capsules
40mg, once per day for 84 days

Placebo Comparator: Placebo
Sugar capsule
Drug: placebo
sugar capsule

Primary Outcome Measures :
  1. 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

  2. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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

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 identifier (NCT number): NCT00560703

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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
Saint 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 R&D
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Study Director: Michael Graeber, MD Galderma R&D
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Responsible Party: Galderma R&D Identifier: NCT00560703    
Other Study ID Numbers: COL-101-BLEPH-201
First Posted: November 20, 2007    Key Record Dates
Results First Posted: January 11, 2012
Last Update Posted: February 18, 2021
Last Verified: December 2011
Additional relevant MeSH terms:
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Skin Diseases
Eyelid Diseases
Eye Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents