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Treatment of Patients With Blepharitis and Facial Rosacea

This study has been completed.
Information provided by (Responsible Party):
Galderma Identifier:
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;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Blepharitis
Dry Eye
Interventions: Drug: COL-101 (doxycycline, USP) capsules
Drug: placebo

  Participant Flow
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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
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 
Adverse Event                0                2 
Protocol Violation                0                2 
Withdrawal by Subject                0                1 
non-compliance                0                1 

  Baseline Characteristics
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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.
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Reporting Groups
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 
Overall Participants Analyzed 
[Units: Participants]
 46   24   70 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   36   15   51 
>=65 years   10   9   19 
[Units: Years]
Mean (Standard Deviation)
 54.5  (13.46)   58.2  (14.27)   55.7  (13.76) 
[Units: Participants]
Female   30   13   43 
Male   16   11   27 
Region of Enrollment 
[Units: Participants]
United States   46   24   70 

  Outcome Measures
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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
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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
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  More Information
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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

Responsible Party: Galderma 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