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Treatment of Patients With Blepharitis and Facial Rosacea
This study has been completed.
Study NCT00560703   Information provided by Galderma
First Received: November 16, 2007   Last Updated: September 30, 2009   History of Changes

November 16, 2007
September 30, 2009
November 2007
May 2009   (final data collection date for primary outcome measure)
Change in Ocular Surface Disease Index Change in bulbar conjunctival hyperemia [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]
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
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 ] [ Designated as safety issue: No ]
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 ]
 
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 doxycycline in the treatment of patients who have both blepharitis and facial rosacea

 
Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
  • Blepharitis
  • Meibomianitis
  • Dry Eye
  • Drug: doxycycline
  • Drug: placebo
  • Active Comparator: doxycycline
  • Placebo Comparator: Sugar capsule
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
80
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
Michael Graeber, Head of Global Clinical Project Management & US Development, Galderma
COL-101-BLEPH-201
Galderma
 
Study Director: Michael Graeber, MD Galderma
Galderma
September 2009

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