Back to resultsTreatment of Patients With Blepharitis and Facial Rosacea
Primary Purpose
Blepharitis, Meibomianitis, Dry Eye
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
COL-101 (doxycycline, USP) capsules
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Blepharitis
Eligibility Criteria
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
Sites / Locations
- Pleasant Valley Ophthalmology
- Warren Scherer, MD
- Kentucky Lions Eye Center
- Washington University School of Medicine
- Marguerite McDonald, MD
- Dean McGee Eye Institute
- Anita Nevyas-Wallace, MD
- Tanner Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
COL-101 (doxycycline, USP) capsules
Placebo
Arm Description
COL-101
Sugar capsule
Outcomes
Primary Outcome Measures
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
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00560703
Brief Title
Treatment of Patients With Blepharitis and Facial Rosacea
Official Title
Efficacy and Safety of COL-101 for the Treatment of Blepharitis in Patients With Facial Rosacea
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine the safety and efficacy of sub-antimicrobial dose COL-101 in the treatment of patients who have both blepharitis and facial rosacea
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharitis, Meibomianitis, Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COL-101 (doxycycline, USP) capsules
Arm Type
Active Comparator
Arm Description
COL-101
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sugar capsule
Intervention Type
Drug
Intervention Name(s)
COL-101 (doxycycline, USP) capsules
Intervention Description
40mg, once per day for 84 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
sugar capsule
Primary Outcome Measure Information:
Title
Change in Bulbar Conjunctival Hyperemia
Description
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
Time Frame
Baseline to Week 12
Title
Change in Ocular Surface Disease Index (OSDI)
Description
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).
Time Frame
Baseline to Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Graeber, MD
Organizational Affiliation
Galderma R&D
Official's Role
Study Director
Facility Information:
Facility Name
Pleasant Valley Ophthalmology
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72212
Country
United States
Facility Name
Warren Scherer, MD
City
Naples
State/Province
Florida
ZIP/Postal Code
34103
Country
United States
Facility Name
Kentucky Lions Eye Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Marguerite McDonald, MD
City
Lynbrook
State/Province
New York
ZIP/Postal Code
11563
Country
United States
Facility Name
Dean McGee Eye Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Anita Nevyas-Wallace, MD
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Tanner Clinic
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treatment of Patients With Blepharitis and Facial Rosacea
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