Expired Study
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Louisville, Kentucky 40202


Purpose:

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.


Study summary:

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.


Criteria:

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


Study is Available At:


Original ID:

lipidtearfilm


NCT ID:

NCT00803452


Secondary ID:

NEI RO-1- EY017094-02


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Louisville


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

31


Enrollment Type:

Actual


Overall Contact Information

Official Name:Gary N Foulks, MD
Principal Investigator
University of Louisville

Study Dates

Start Date:July 2008
Completion Date:December 2010
Completion Type:Actual
Primary Completion Date:December 2010
Primary Completion Type:Actual
Verification Date:November 2017
Last Changed Date:November 28, 2017
First Received Date:December 1, 2008
First Results Date:April 7, 2017

Study Outcomes

Outcome Type:Primary Outcome
Measure:Global Response to Therapy
Time Frame:4 weeks
Safety Issues:False
Description: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

Study Interventions

Intervention Type:Drug
Name:doxycycline
Description:Oral doxycycline 100mg bid
Arm Name:Doxycycline
Other Name:Minocycline
Intervention Type:Drug
Name:azithromycin
Description:topical 1% azithromycin daily to eye
Arm Name:azithromycin
Other Name:Azasite

Study Arms

Study Arm Type:Active Comparator
Arm Name:azithromycin
Description:Topical azithromycin daily to the conjunctival culdesac
Study Arm Type:Active Comparator
Arm Name:Doxycycline
Description:Oral doxycycline

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Louisville

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
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.
PMID:20489573
Reference Type:Results Reference
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.
PMID:22668581

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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