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

NCT ID: NCT00803452

Last Updated: 2017-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2010-12-31

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.

Conditions

Blepharitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Doxycycline

Oral doxycycline

Group Type: ACTIVE_COMPARATOR

doxycycline

Intervention Type: DRUG

Oral doxycycline 100mg bid

azithromycin

Topical azithromycin daily to the conjunctival culdesac

Group Type: ACTIVE_COMPARATOR

azithromycin

Intervention Type: DRUG

topical 1% azithromycin daily to eye

Interventions

doxycycline

Oral doxycycline 100mg bid

Intervention Type: DRUG

azithromycin

topical 1% azithromycin daily to eye

Intervention Type: DRUG

Other Intervention Names

Minocycline; Azasite

Eligibility Criteria

Inclusion Criteria

• Meibomian gland dysfunction

Exclusion Criteria

• Lid margin scarring; herpetic blepharitis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Douglas Bourchman

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gary N Foulks, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

Kentucky Lions Eye Center

Louisville, Kentucky, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 22668581 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20489573 (View on PubMed)

Borchman D, Foulks GN, Yappert MC, Bell J, Wells E, Neravetla S, Greenstone V. Human meibum lipid conformation and thermodynamic changes with meibomian-gland dysfunction. Invest Ophthalmol Vis Sci. 2011 Jun 1;52(6):3805-17. doi: 10.1167/iovs.10-6514.

Reference Type: DERIVED

PMID: 21398284 (View on PubMed)

Other Identifiers

NEI RO-1- EY017094-02

Identifier Type: -

Identifier Source: secondary_id

lipidtearfilm

Identifier Type: -

Identifier Source: org_study_id