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

Blepharitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00803452
• Other study ID #: lipidtearfilm
• Secondary ID: NEI RO-1- EY0170
• Status: Completed
• Phase: Phase 4
• First received: December 1, 2008
• Last updated: November 28, 2017
• Start date: July 2008
• Est. completion date: December 2010

Study information

• Verified date: November 2017
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Meibomian gland dysfunction

Exclusion Criteria:

• Lid margin scarring; herpetic blepharitis

Related Conditions & MeSH terms

• Blepharitis

Intervention

Drug:
• doxycycline
Oral doxycycline 100mg bid
• azithromycin
topical 1% azithromycin daily to eye

Locations

Country	Name	City	State
United States	Kentucky Lions Eye Center	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

References & Publications (2)

Foulks GN, Borchman D, Yappert M, Kakar S. Topical azithromycin and oral doxycycline therapy of meibomian gland dysfunction: a comparative clinical and spectroscopic pilot study. Cornea. 2013 Jan;32(1):44-53. doi: 10.1097/ICO.0b013e318254205f. — View Citation

Foulks GN, Borchman D, Yappert M, Kim SH, McKay JW. Topical azithromycin therapy for meibomian gland dysfunction: clinical response and lipid alterations. Cornea. 2010 Jul;29(7):781-8. doi: 10.1097/ICO.0b013e3181cda38f. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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