Treatment of Patients With Blepharitis and Facial Rosacea

NCT00560703 | Completed Phase 2 Results

• 1 other identifier: COL-101-BLEPH-201
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 8

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

Conditions

Blepharitis; Meibomianitis; Dry Eye

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

COL-101 (doxycycline, USP) capsules

ACTIVE COMPARATOR

COL-101

Drug: COL-101 (doxycycline, USP) capsules

Placebo

PLACEBO COMPARATOR

Sugar capsule

Drug: placebo

Interventions

COL-101 (doxycycline, USP) capsules DRUG

40mg, once per day for 84 days

COL-101 (doxycycline, USP) capsules

placebo DRUG

sugar capsule

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• blepharitis
• facial rosacea

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (8)

Pleasant Valley Ophthalmology

Little Rock, Arkansas, 72212, United States

Location

Warren Scherer, MD

Naples, Florida, 34103, United States

Location

Kentucky Lions Eye Center

Louisville, Kentucky, 40202, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Marguerite McDonald, MD

Lynbrook, New York, 11563, United States

Location

Dean McGee Eye Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Anita Nevyas-Wallace, MD

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Tanner Clinic

Layton, Utah, 84041, United States

Location

MeSH Terms

Conditions

Blepharitis; Meibomitis; Dry Eye Syndromes

Interventions

Doxycycline; Capsules

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Lacrimal Apparatus Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Michael Graeber
• Organization: Organization: Galderma R&D, Inc

clinicaltrials@galderma.com

609-409-7701

Study Officials

• Michael Graeber, MD

  Galderma R&D

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2007
• First Posted: November 20, 2007
• Study Start: November 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: July 1, 2009
• Last Updated: February 18, 2021
• Results First Posted: January 11, 2012

Record last verified: 2011-12

Locations

US (8)