Treatment of Patients With Blepharitis and Facial Rosacea

Galderma R&D70 enrolled

Overview

To determine the safety and efficacy of sub-antimicrobial dose COL-101 in the treatment of patients who have both blepharitis and facial rosacea

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Blepharitis Meibomianitis Dry Eye

Interventions

COL-101 (doxycycline, USP) capsulesDRUG

40mg, once per day for 84 days

placeboDRUG

sugar capsule

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

Pleasant Valley Ophthalmology

Little Rock, Arkansas, United States

Warren Scherer, MD

Naples, Florida, United States

Kentucky Lions Eye Center

Louisville, Kentucky, United States

Washington University School of Medicine

St Louis, Missouri, United States

Outcomes

Primary Outcomes

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

Time frame: 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).

Time frame: Baseline to Week 12

Data from ClinicalTrials.gov

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