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NCT00560703 Clinical Trial

Treatment of Patients With Blepharitis and Facial Rosacea

Dry Eye Clinical Trial

Official title:
Efficacy and Safety of COL-101 for the Treatment of Blepharitis in Patients With Facial Rosacea

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00560703
Other study ID # COL-101-BLEPH-201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 2007
Est. completion date July 2009

Study information
Verified date December 2011
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date July 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• COL-101 (doxycycline, USP) capsules
40mg, once per day for 84 days
• placebo
sugar capsule

Locations
Country Name City State
United States Anita Nevyas-Wallace, MD Bala-Cynwyd Pennsylvania
United States Tanner Clinic Layton Utah
United States Pleasant Valley Ophthalmology Little Rock Arkansas
United States Kentucky Lions Eye Center Louisville Kentucky
United States Marguerite McDonald, MD Lynbrook New York
United States Warren Scherer, MD Naples Florida
United States Dean McGee Eye Institute Oklahoma City Oklahoma
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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