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

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.

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Key information

Conditions

Blepharitis Eye Diseases Eyelid Diseases Meibomian Gland Dysfunction

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kentucky Lions Eye Center

Louisville, Kentucky, 40202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Meibomian gland dysfunction

Exclusion criteria

Lid margin scarring; herpetic blepharitis

Treatment and study plan

Doxycycline

Drug

Oral doxycycline 100mg bid

Other names: Minocycline

Azithromycin

Drug

topical 1% azithromycin daily to eye

Other names: Azasite

Primary outcomes

Global Response to Therapy

Time frame: 4 weeks

Global Response to Therapy (itch, dryness, burning and swelling of eyes) as assessed with a questionnaire completed by the subjects. The questionnaire asked subjects to rate their improvement on a scale from 4 to 0 with 4 being resolution of symptoms and 0 being no improvement. Data reported here represent the number of eye of subjects that reported that their symptoms were resolved or improved in each eye.

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Dec 5, 2008
Registry last updated: Dec 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed