Treatment of Patients With Blepharitis and Facial Rosacea

Phase 2

Completed

• Conditions: Meibomianitis; Blepharitis; Dry Eye
• Interventions: Drug: COL-101 (doxycycline, USP) capsules; Drug: placebo

• Registration Number: NCT00560703
• Lead Sponsor: Galderma R&D

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-16
• Study First Submitted QC: 2007-11-16
• Study First Posted: 2007-11-20
• Primary Completion: 2009-05
• Study Completion: 2009-07
• Results First Submitted: 2011-04-28
• Status Verified: 2011-12
• Results First Submitted QC: 2011-12-09
• Results First Posted: 2012-01-11
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COL-101 (doxycycline, USP) capsules	COL-101 (doxycycline, USP) capsules	COL-101
Placebo	placebo	Sugar capsule

Primary Outcome Measures

Name	Time	Method
Change in Bulbar Conjunctival Hyperemia	Baseline to Week 12	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)	Baseline to Week 12	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).

Trial Locations

Locations (8)

Tanner Clinic; 🇺🇸 Layton, Utah, United States

Anita Nevyas-Wallace, MD; 🇺🇸 Bala-Cynwyd, Pennsylvania, United States

Kentucky Lions Eye Center; 🇺🇸 Louisville, Kentucky, United States

Warren Scherer, MD; 🇺🇸 Naples, Florida, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Pleasant Valley Ophthalmology; 🇺🇸 Little Rock, Arkansas, United States

Dean McGee Eye Institute; 🇺🇸 Oklahoma City, Oklahoma, United States

Marguerite McDonald, MD; 🇺🇸 Lynbrook, New York, United States