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A Prospective Clinical Study Assessing the Effects of Tetracycline Antibiotic on Tear Film and Tear Lipid Composition Within a Population of Patients Diagnosed With Blepharitis and Dry Eye Disease

This study has been terminated.
( The PI has elected to terminate study at this time )

Sponsored by: University of Texas Southwestern Medical Center
Information provided by: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00355459
  Purpose

The purpose of this research project is to determine the effects of oral tetracycline such as Minocycline (Minocin) on tear film composition and tear lipid (meibomian gland secretions) characteristics in patients with chronic Blepharitis and associated dry eyes.


Condition Intervention
Dry Eye Syndrome
Drug: Tetracycline: Doxycycline analog

MedlinePlus related topics:   Antibiotics    Eye Diseases   

ChemIDplus related topics:   Doxycycline    Doxycycline calcium    Doxycycline hyclate    Lipids    Tetracycline    Tetracycline hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   A Prospective Clinical Study Assessing the Effects of Tetracycline Antibiotic on Tear Film and Tear Lipid Composition Within a Population of Patients Diagnosed With Blepharitis and Dry Eye Disease

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Evaporometry
  • Fluorophotometery
  • Meibomian gland expression and lipid analysis

Secondary Outcome Measures:
  • Schirmers Testing
  • TBUT
  • Bacteriology
  • Transillumination & Meibography

Enrollment:   0
Study Start Date:   August 2005
Study Completion Date:   April 2007

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years to 88 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria: Patients over 18 years of age, patient willing and able to comply with the protocol. Insidious onset and greater than three month's duration of ocular symptoms consistent with dry eye and meibomian gland disease. Ocular surface vital staining consistent with aqueous deficient dry eyes with less than +1 conjunctival injection and no more than minimal lid inflammation. Normal controls will also be tested for this trial.

Exclusion Criteria: Any patient with punctual occlusion or punctual plugs within the past 2 months. Patients with active ocular infection or inflammatory disease, history of herpetic keratitis, history of retinal detachment, concurrent contact lens use during the trial period, ocular surgery within the past six months, patients with glaucoma, anterior membrane dystrophy, active trichiasis or any eyelid globe malposition abnormality, e.g., entropion, ectropion, etc. Patients with epiphora (excessive tearing). Moreover, patients taking medications known to effect aqueous tear production or meibomian secretions or use of tetracycline or tetracycline analogs for treatment of other medical conditions within the past 3 months. Patient must not have participated in (or be currently participating in) any investigational therapeutic drug or device trial within the previous 30 days prior to their start date for this trial. In addition, any patient suffering from organic brain syndromes or major psychiatric disorder that would interfere with compliance or subjective reporting will be discouraged from participating in this trial.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355459

Locations
United States, Texas
University of Texas Southwestern Medical Center at Dallas    
      Dallas, Texas, United States, 75390-8866

Sponsors and Collaborators
University of Texas Southwestern Medical Center

Investigators
Principal Investigator:     James P. McCulley, M.D.     University of Texas Southwestern Medical Center at Dallas    
  More Information

Study ID Numbers:   082005-026
First Received:   July 20, 2006
Last Updated:   June 4, 2008
ClinicalTrials.gov Identifier:   NCT00355459
Health Authority:   United States: Food and Drug Administration

Keywords provided by University of Texas Southwestern Medical Center:
Meibomian Gland Dystrophy  

Study placed in the following topic categories:
Lacerations
Eye Diseases
Blepharitis
Lacrimal Apparatus Diseases
Dry Eye Syndromes
Tetracycline
Doxycycline

Additional relevant MeSH terms:
Anti-Infective Agents
Antiprotozoal Agents
Disease
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Pharmacologic Actions
Protein Synthesis Inhibitors
Anti-Bacterial Agents
Antimalarials
Antiparasitic Agents
Pathologic Processes
Syndrome
Therapeutic Uses
Eyelid Diseases

ClinicalTrials.gov processed this record on September 04, 2008




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