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)
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00355459
First received: July 20, 2006
Last updated: March 21, 2011
Last verified: May 2007
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00355459     History of Changes
Other Study ID Numbers: 082005-026
Study First Received: July 20, 2006
Last Updated: March 21, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Blepharitis
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Diseases
Eyelid Diseases
Lacrimal Apparatus Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Tetracycline
Anti-Bacterial Agents
Doxycycline
Doxycycline hyclate
Antibiotics, Antitubercular
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Antitubercular Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on July 28, 2014