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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00803452
Recruitment Status : Completed
First Posted : December 5, 2008
Results First Posted : December 22, 2017
Last Update Posted : December 22, 2017
Information provided by (Responsible Party):
Douglas Bourchman, 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.

Condition or disease Intervention/treatment Phase
Blepharitis Drug: doxycycline Drug: azithromycin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lipids of the Human Tear Film and Their Effect on Tear Stability
Study Start Date : July 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
Active Comparator: Doxycycline
Oral doxycycline
Drug: doxycycline
Oral doxycycline 100mg bid
Other Name: Minocycline

Active Comparator: azithromycin
Topical azithromycin daily to the conjunctival culdesac
Drug: azithromycin
topical 1% azithromycin daily to eye
Other Name: Azasite

Primary Outcome Measures :
  1. Global Response to Therapy [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Meibomian gland dysfunction

Exclusion Criteria:

  • Lid margin scarring; herpetic blepharitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00803452

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United States, Kentucky
Kentucky Lions Eye Center
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
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Principal Investigator: Gary N Foulks, MD University of Louisville
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Douglas Bourchman, Professor, University of Louisville Identifier: NCT00803452    
Other Study ID Numbers: lipidtearfilm
NEI RO-1- EY017094-02
First Posted: December 5, 2008    Key Record Dates
Results First Posted: December 22, 2017
Last Update Posted: December 22, 2017
Last Verified: November 2017
Keywords provided by Douglas Bourchman, University of Louisville:
Meibomian gland dysfunction
Lid margin disease
essential fatty acid
Additional relevant MeSH terms:
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Eyelid Diseases
Eye Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents