NCT00560703|CompletedPhase 2Results
Treatment of Patients With Blepharitis and Facial Rosacea
Efficacy and Safety of COL-101 for the Treatment of Blepharitis in Patients With Facial Rosacea
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Sponsor study identifier
interventional
70
1 country
8
Study Start
November 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2009
Actual (reported)Study Completion
July 2009
Actual (reported)To determine the safety and efficacy of sub-antimicrobial dose COL-101 in the treatment of patients who have both blepharitis and facial rosacea
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2007
Date type not reportedThis date has not been verified as actual or estimated.
November 16, 2007
Actual (reported)November 20, 2007
Actual (reported)May 2009
Actual (reported)July 2009
Actual (reported)January 11, 2012
Actual (reported)Change in Bulbar Conjunctival Hyperemia
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
Baseline to Week 12
Change in Ocular Surface Disease Index (OSDI)
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).
Baseline to Week 12
COL-101
Sugar capsule
40mg, once per day for 84 days
sugar capsule
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Pleasant Valley Ophthalmology
Little Rock, Arkansas, 72212, United States
Warren Scherer, MD
Naples, Florida, 34103, United States
Kentucky Lions Eye Center
Louisville, Kentucky, 40202, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Marguerite McDonald, MD
Lynbrook, New York, 11563, United States
Dean McGee Eye Institute
Oklahoma City, Oklahoma, 73104, United States
Anita Nevyas-Wallace, MD
Bala-Cynwyd, Pennsylvania, 19004, United States
Michael Graeber, MD
Galderma R&D
70 participants (actual enrollment reported by the registry).
First Submitted
November 16, 2007
First Posted
November 20, 2007
Study Start
November 2007
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Tanner Clinic
Layton, Utah, 84041, United States
Primary Completion
May 2009
Actual (reported)Study Completion
July 2009
Actual (reported)Last Updated
February 18, 2021
Results First Posted
January 11, 2012
Record last verified: 2011-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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