Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Results First Received: April 28, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Blepharitis
Meibomianitis
Dry Eye
Interventions: Drug: COL-101 (doxycycline, USP) capsules
Drug: placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment time was approximately 6 months in 8 US clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were screened for eligibility within 6 weeks prior to the baseline visit. This 12-week study employed a two-treatment, parallel-group design with subjects randomized in a 2:1 ratio to active drug or placebo.

Reporting Groups
  Description
COL-101 (Doxycycline, USP) Capsules 40 MG, Once per day for 84 days
Placebo Sugar capsule, once per day for 84 days

Participant Flow:   Overall Study
    COL-101 (Doxycycline, USP) Capsules     Placebo  
STARTED     46     24  
COMPLETED     46     18  
NOT COMPLETED     0     6  
Adverse Event                 0                 2  
Protocol Violation                 0                 2  
Withdrawal by Subject                 0                 1  
non-compliance                 0                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
COL-101 (Doxycycline, USP) Capsules 40 MG, Once per day for 84 days
Placebo Sugar capsule, once per day for 84 days
Total Total of all reporting groups

Baseline Measures
    COL-101 (Doxycycline, USP) Capsules     Placebo     Total  
Number of Participants  
[units: participants]
  46     24     70  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     36     15     51  
>=65 years     10     9     19  
Age  
[units: years]
Mean ± Standard Deviation
  54.5  ± 13.46     58.2  ± 14.27     55.7  ± 13.76  
Gender  
[units: participants]
     
Female     30     13     43  
Male     16     11     27  
Region of Enrollment  
[units: participants]
     
United States     46     24     70  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Bulbar Conjunctival Hyperemia   [ Time Frame: Baseline to Week 12 ]

2.  Primary:   Change in Ocular Surface Disease Index (OSDI)   [ Time Frame: Baseline to Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Michael Graeber
Organization: Organization: Galderma R&D, Inc
phone: 609-409-7701
e-mail: clinicaltrials@galderma.com


No publications provided


Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT00560703     History of Changes
Other Study ID Numbers: COL-101-BLEPH-201
Study First Received: November 16, 2007
Results First Received: April 28, 2011
Last Updated: December 9, 2011
Health Authority: United States: Food and Drug Administration