NCT00803452

Lipids of the Human Tear Film and Their Effect on Tear Stability

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed description

Subjects with meibomian gland dysfunction undergo expression of the meibomian gland secretion prior to beginning treatment with either oral doxycycline or topical azithromycin solution. Doxycycline is dosed at 100 mg bid; topical azithromycin is delivered once per day as a 1% solution. Treatment with doxycycline 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.

Conditions

• Blepharitis

Interventions

Type	Name	Description
DRUG	doxycycline	Oral doxycycline 100mg bid
DRUG	azithromycin	topical 1% azithromycin daily to eye

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2008-12-05
• Last updated: 2017-12-22
• Results posted: 2017-12-22

Locations

1 site across 1 country: United States