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

Study Overview
=================
Brief 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.

Official Title
-----------------
Lipids of the Human Tear Film and Their Effect on Tear Stability

Conditions
-----------------
Blepharitis

Intervention / Treatment
-----------------
* Drug: doxycycline
* Drug: azithromycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meibomian gland dysfunction Exclusion Criteria: Lid margin scarring; herpetic blepharitis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Doxycycline<br>Oral doxycycline | Drug: doxycycline<br>* Oral doxycycline 100mg bid<br>* Other names: Minocycline;|
| Active Comparator: azithromycin<br>Topical azithromycin daily to the conjunctival culdesac | Drug: azithromycin<br>* topical 1% azithromycin daily to eye<br>* Other names: Azasite;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Response to Therapy | 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. | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Meibomian gland dysfunction, Lid margin disease, doxycycline, azithromycin, essential fatty acid