Lipids of the Human Tear Film and Their Effect on Tear Stability
Information source: University of Louisville
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Blepharitis
Intervention: doxycycline (Drug); essential fatty acid (Drug); azithromycin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Louisville Official(s) and/or principal investigator(s):
Gary N Foulks, MD, Principal Investigator, Affiliation: University of Louisville
Overall contact:
Gary N Foulks, MD, Phone: 502-852-6150, Email: gnfoul01@louisville.edu
Summary
This prospective, randomized, comparative clinical trial evaluates the effect of either oral
doxycycline, oral essential fatty acid, or topical azithromycin to modify the secretions of
the meibomian gland in subjects with meibomian gland dysfunction and/or dry eye disease.
Clinical Details
Official title: Lipids of the Human Tear Film and Their Effect on Tear Stability
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Inflammation of eyelid (Clinical; Phase transition temp (Laboratory)
Secondary outcome: Character of meibomian gland secretion
Detailed description:
Subjects with meibomian gland dysfunction undergo expression of the meibomian gland
secretion prior to beginning treatment with either oral doxycycline, oral essential fatty
acids, or topical azithromycin solution. Doxycycline is dosed at 100 mg bid; essential
fatty acid is dosed at 1000 mg per day; topical azithromycin is delivered once per day as a
1% solution. Treatment with doxycycline is for two months; treatment with essential fatty
acids is for two months; treatment with topical azithromycin is for one month. Following
treatment, meibomian glands are again expressed and the lipids measured by spectroscopy
(FTIR, MALDI-TOF, NMR)for characterization of structure and function. Analysis for presence
of doxcycline or azithromycin is also performed. Changes in lipid parameters are correlated
with clinical signs and symptoms of disease.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Meibomian gland dysfunction
Exclusion Criteria:
- Lid margin scarring; herpetic blepharitis
Locations and Contacts
Gary N Foulks, MD, Phone: 502-852-6150, Email: gnfoul01@louisville.edu
Kentucky Lions Eye Center, Louisville, Kentucky 40202, United States; Recruiting
Gary N Foulks, MD, Phone: 502-852-6150, Email: gnfoul01@louisville.edu
Gary N Foulks, MD, Principal Investigator
Additional Information
Starting date: July 2008
Ending date: September 2010
Last updated: August 12, 2009
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