Back to results

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

Primary Purpose

Blepharitis

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

doxycycline

azithromycin

About this trial

This is an interventional treatment trial for Blepharitis focused on measuring Meibomian gland dysfunction, Lid margin disease, doxycycline, azithromycin, essential fatty acid

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Meibomian gland dysfunction

Exclusion Criteria:

Lid margin scarring; herpetic blepharitis

Sites / Locations

Kentucky Lions Eye Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Doxycycline

azithromycin

Arm Description

Oral doxycycline

Topical azithromycin daily to the conjunctival culdesac

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00803452

First Posted

December 1, 2008

Last Updated

November 28, 2017

Sponsor

University of Louisville

1. Study Identification

Unique Protocol Identification Number

NCT00803452

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Louisville

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Blepharitis

Keywords

Meibomian gland dysfunction, Lid margin disease, doxycycline, azithromycin, essential fatty acid

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Doxycycline

Arm Type

Active Comparator

Arm Description

Oral doxycycline

Arm Title

azithromycin

Arm Type

Active Comparator

Arm Description

Topical azithromycin daily to the conjunctival culdesac

Intervention Type

Drug

Intervention Name(s)

doxycycline

Other Intervention Name(s)

Minocycline

Intervention Description

Oral doxycycline 100mg bid

Intervention Type

Drug

Intervention Name(s)

azithromycin

Other Intervention Name(s)

Azasite

Intervention Description

topical 1% azithromycin daily to eye

Primary Outcome Measure Information:

Title

Global Response to Therapy

Description

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Meibomian gland dysfunction Exclusion Criteria: Lid margin scarring; herpetic blepharitis

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gary N Foulks, MD

Organizational Affiliation

University of Louisville

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kentucky Lions Eye Center

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22668581

Citation

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.

Results Reference

result

PubMed Identifier

20489573

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.

Results Reference

result

PubMed Identifier

21398284

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs