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

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ClinicalTrials.gov Identifier: NCT00803452
Recruitment Status : Completed
First Posted : December 5, 2008
Results First Posted : December 22, 2017
Last Update Posted : December 22, 2017
Sponsor:
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.

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

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.



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

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 ClinicalTrials.gov identifier (NCT number): NCT00803452


Locations
United States, Kentucky
Kentucky Lions Eye Center
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Gary N Foulks, MD University of Louisville

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Douglas Bourchman, Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT00803452     History of Changes
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
doxycycline
azithromycin
essential fatty acid

Additional relevant MeSH terms:
Blepharitis
Eyelid Diseases
Eye Diseases
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents