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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
History of Changes

November 16, 2007
December 9, 2011
November 2007
May 2009   (final data collection date for primary outcome measure)
  • 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).
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 ClinicalTrials.gov 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 ]
Not Provided
Not Provided
 
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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
    COL-101
    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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00560703
COL-101-BLEPH-201
No
Galderma
Galderma
Not Provided
Study Director: Michael Graeber, MD Galderma
Galderma
December 2011

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