Treatment of Patients With Blepharitis and Facial Rosacea - Tabular View

Tracking Information

First Received Date ^ICMJE

November 16, 2007

Last Updated Date

September 30, 2009

Start Date ^ICMJE

November 2007

Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in Ocular Surface Disease Index Change in bulbar conjunctival hyperemia [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change in Ocular Surface Disease Index Change in bulbar conjunctival hyperemia [ Time Frame: Baseline to end of study ]

Change History

Complete list of historical versions of study NCT00560703 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in Schirmer tear test at each study visit Change in tear break-up time at each study visit Change in meibum character/fluidity at each study visit Change in meibomian gland inspissation at each study visit [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Treatment of Patients With Blepharitis and Facial Rosacea

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Blepharitis
Meibomianitis
Dry Eye

Intervention ^ICMJE

Drug: doxycycline
Drug: placebo

Study Arms / Comparison Groups

Active Comparator: doxycycline
Placebo Comparator: Sugar capsule

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2009

Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00560703

Responsible Party

Michael Graeber, Head of Global Clinical Project Management & US Development, Galderma

Study ID Numbers ^ICMJE

COL-101-BLEPH-201

Study Sponsor ^ICMJE

Galderma

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Michael Graeber, MD

Galderma

Information Provided By

Galderma

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP