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
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ClinicalTrials.gov Identifier: NCT00355459 |
Recruitment Status :
Withdrawn
(The PI has elected to terminate study at this time)
First Posted : July 24, 2006
Last Update Posted : December 13, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dry Eye Syndrome | Drug: Tetracycline: Doxycycline analog | Not Applicable |

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 |

- Evaporometry
- Fluorophotometery
- Meibomian gland expression and lipid analysis
- Schirmers Testing
- TBUT
- Bacteriology
- Transillumination & Meibography

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Ages Eligible for Study: | 18 Years to 88 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00355459
United States, Texas | |
University of Texas Southwestern Medical Center at Dallas | |
Dallas, Texas, United States, 75390-8866 |
Principal Investigator: | James P. McCulley, M.D. | University of Texas, Southwestern Medical Center at Dallas |
ClinicalTrials.gov Identifier: | NCT00355459 |
Other Study ID Numbers: |
082005-026 |
First Posted: | July 24, 2006 Key Record Dates |
Last Update Posted: | December 13, 2018 |
Last Verified: | December 2018 |
Meibomian Gland Dystrophy |
Keratoconjunctivitis Sicca Dry Eye Syndromes Eye Diseases Blepharitis Keratoconjunctivitis Conjunctivitis Conjunctival Diseases Keratitis Corneal Diseases Lacrimal Apparatus Diseases Eyelid Diseases |
Doxycycline Tetracycline Anti-Bacterial Agents Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |