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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Dry Eye Syndrome	Drug: Tetracycline: Doxycycline analog	Not Applicable

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	0 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	August 2005
Actual Study Completion Date :	April 2007

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. Evaporometry
2. Fluorophotometery
3. Meibomian gland expression and lipid analysis

Secondary Outcome Measures :

1. Schirmers Testing
2. TBUT
3. Bacteriology
4. Transillumination & Meibography

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 88 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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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

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ClinicalTrials.gov Identifier:	NCT00355459 History of Changes
Other Study ID Numbers:	082005-026
First Posted:	July 24, 2006
Last Update Posted:	March 23, 2011
Last Verified:	May 2007

Keywords provided by University of Texas Southwestern Medical Center:

Meibomian Gland Dystrophy

Additional relevant MeSH terms:

Keratoconjunctivitis Sicca; Dry Eye Syndromes; Eye Diseases; Blepharitis; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Lacrimal Apparatus Diseases; Eyelid Diseases	Anti-Bacterial Agents; Doxycycline; Tetracycline; Anti-Infective Agents; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents; Protein Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action