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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of Louisville.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Louisville
ClinicalTrials.gov Identifier:
NCT00803452
First received: December 1, 2008
Last updated: November 23, 2010
Last verified: June 2010
  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.


Condition Intervention Phase
Blepharitis
Drug: doxycycline
Drug: essential fatty acid
Drug: azithromycin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lipids of the Human Tear Film and Their Effect on Tear Stability

Resource links provided by NLM:


Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Inflammation of eyelid (Clinical; Phase transition temp (Laboratory) [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Character of meibomian gland secretion [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: July 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Doxycycline
Oral doxycycline
Drug: doxycycline
Oral doxycycline 100mg bid
Other Name: Minocycline
Active Comparator: essential fatty acid
Oral essential fatty acid
Drug: essential fatty acid
Oral essential fatty acid 1000mg per day
Other Name: Fish Oil; Flax Seed Oil
Active Comparator: azithromycin
Topical azithromycin daily to the conjunctival culdesac
Drug: azithromycin
topical 1% azithromycin daily to eye
Other Name: Azasite

Detailed Description:

Subjects with meibomian gland dysfunction undergo expression of the meibomian gland secretion prior to beginning treatment with either oral doxycycline, oral essential fatty acids, or topical azithromycin solution. Doxycycline is dosed at 100 mg bid; essential fatty acid is dosed at 1000 mg per day; topical azithromycin is delivered once per day as a 1% solution. Treatment with doxycycline is for two months; treatment with essential fatty acids 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Meibomian gland dysfunction

Exclusion Criteria:

  • Lid margin scarring; herpetic blepharitis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00803452

Contacts
Contact: Gary N Foulks, MD 502-852-6150 gnfoul01@louisville.edu
Contact: Douglas Borchman, PhD 502-852-7435 borchman@louisville.edu

Locations
United States, Kentucky
Kentucky Lions Eye Center Recruiting
Louisville, Kentucky, United States, 40202
Contact: Gary N Foulks, MD    502-852-6150    gnfoul01@louisville.edu   
Principal Investigator: Gary N Foulks, MD         
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Gary N Foulks, MD University of Louisville
  More Information

No publications provided by University of Louisville

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gary N. Foulks, MD, University of Louisville
ClinicalTrials.gov Identifier: NCT00803452     History of Changes
Other Study ID Numbers: lipidtearfilm, NEI RO-1- EY017094-02
Study First Received: December 1, 2008
Last Updated: November 23, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Louisville:
Meibomian gland dysfunction
Lid margin disease
doxycycline
azithromycin
essential fatty acid

Additional relevant MeSH terms:
Eyelid Diseases
Blepharitis
Eye Diseases
Doxycycline
Doxycycline hyclate
Minocycline
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on April 14, 2014