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

University of Louisville (UOFL)

Status and phase: Completed; Phase 4

Conditions: Blepharitis

Treatments: Drug: doxycycline; Drug: azithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT00803452

NEI RO-1- EY017094-02

lipidtearfilm

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Meibomian gland dysfunction

Exclusion criteria

• Lid margin scarring; herpetic blepharitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Doxycycline

Active Comparator group

Description:

Oral doxycycline

Treatment:

Drug: doxycycline

azithromycin

Active Comparator group

Description:

Topical azithromycin daily to the conjunctival culdesac

Treatment:

Drug: azithromycin