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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

Tracking Information
First Submitted Date  ICMJE December 1, 2008
First Posted Date  ICMJE December 5, 2008
Results First Submitted Date  ICMJE April 7, 2017
Results First Posted Date  ICMJE December 22, 2017
Last Update Posted Date December 22, 2017
Study Start Date  ICMJE July 2008
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 3, 2008)
Inflammation of eyelid (Clinical; Phase transition temp (Laboratory) [ Time Frame: 2 months ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2008)
Character of meibomian gland secretion [ Time Frame: 2 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lipids of the Human Tear Film and Their Effect on Tear Stability
Official Title  ICMJE Lipids of the Human Tear Film and Their Effect on Tear Stability
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Blepharitis
Intervention  ICMJE
  • Drug: doxycycline
    Oral doxycycline 100mg bid
    Other Name: Minocycline
  • Drug: azithromycin
    topical 1% azithromycin daily to eye
    Other Name: Azasite
Study Arms  ICMJE
  • Active Comparator: Doxycycline
    Oral doxycycline
    Intervention: Drug: doxycycline
  • Active Comparator: azithromycin
    Topical azithromycin daily to the conjunctival culdesac
    Intervention: Drug: azithromycin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 28, 2017)
31
Original Estimated Enrollment  ICMJE
 (submitted: December 3, 2008)
400
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Meibomian gland dysfunction

Exclusion Criteria:

  • Lid margin scarring; herpetic blepharitis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00803452
Other Study ID Numbers  ICMJE lipidtearfilm
NEI RO-1- EY017094-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Douglas Bourchman, University of Louisville
Study Sponsor  ICMJE University of Louisville
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gary N Foulks, MD University of Louisville
PRS Account University of Louisville
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP