|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
||||||||||||||||||||||||||||||||||||
| 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 |
| 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 |
| 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 |
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| United States, Texas | |||||
| University of Texas Southwestern Medical Center at Dallas | |||||
| Dallas, Texas, United States, 75390-8866 | |||||
| University of Texas Southwestern Medical Center |
| 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 |
|
|
|
|
|