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 : January 11, 2012
Information provided by (Responsible Party):

November 16, 2007
November 20, 2007
April 28, 2011
January 11, 2012
January 11, 2012
November 2007
May 2009   (Final data collection date for primary outcome measure)
  • 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).

Change in Ocular Surface Disease Index Change in bulbar conjunctival hyperemia [ Time Frame: Baseline to end of study ]
Complete list of historical versions of study NCT00560703 on Archive Site
Not Provided
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 ]
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Treatment of Patients With Blepharitis and Facial Rosacea
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
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Blepharitis
  • Meibomianitis
  • Dry Eye
  • Drug: COL-101 (doxycycline, USP) capsules
    40mg, once per day for 84 days
  • Drug: placebo
    sugar capsule
  • Active Comparator: COL-101 (doxycycline, USP) capsules
    Intervention: Drug: COL-101 (doxycycline, USP) capsules
  • Placebo Comparator: Placebo
    Sugar capsule
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2009
May 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
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Not Provided
Study Director: Michael Graeber, MD Galderma
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP