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

Phase 4

Completed

• Conditions: Blepharitis
• Interventions: Drug: doxycycline; Drug: azithromycin

• Registration Number: NCT00803452
• Lead Sponsor: University of Louisville

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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-12-01
• Study First Submitted QC: 2008-12-03
• Study First Posted: 2008-12-05
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2017-04-07
• Status Verified: 2017-11
• Results First Submitted QC: 2017-11-28
• Last Update Submitted: 2017-11-28
• Results First Posted: 2017-12-22
• Last Update Posted: 2017-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Meibomian gland dysfunction

Exclusion Criteria

• Lid margin scarring; herpetic blepharitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Doxycycline	doxycycline	Oral doxycycline
azithromycin	azithromycin	Topical azithromycin daily to the conjunctival culdesac

Primary Outcome Measures

Name	Time	Method
Global Response to Therapy	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.

Trial Locations

Locations (1)

Kentucky Lions Eye Center; 🇺🇸 Louisville, Kentucky, United States