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

Sponsor
University of Louisville (Other)
Overall Status
Completed
CT.gov ID
NCT00803452
Collaborator
(none)
31
Enrollment
1
Location
2
Arms
29
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
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 Design

Study Type:
Interventional
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 :
Jul 1, 2008
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Dec 1, 2010

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: Doxycycline

Oral doxycycline

Drug: doxycycline
Oral doxycycline 100mg bid
Other Names:
  • Minocycline
  • Active Comparator: azithromycin

    Topical azithromycin daily to the conjunctival culdesac

    Drug: azithromycin
    topical 1% azithromycin daily to eye
    Other Names:
  • Azasite
  • Outcome Measures

    Primary Outcome Measures

    1. Global Response to Therapy [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Meibomian gland dysfunction
    Exclusion Criteria:
    • Lid margin scarring; herpetic blepharitis

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Kentucky Lions Eye CenterLouisvilleKentuckyUnited States40202

    Sponsors and Collaborators

    • University of Louisville

    Investigators

    • Principal Investigator: Gary N Foulks, MD, University of Louisville

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Douglas Bourchman, Professor, University of Louisville
    ClinicalTrials.gov Identifier:
    NCT00803452
    Other Study ID Numbers:
    • lipidtearfilm
    • NEI RO-1- EY017094-02
    First Posted:
    Dec 5, 2008
    Last Update Posted:
    Dec 22, 2017
    Last Verified:
    Nov 1, 2017
    Keywords provided by Douglas Bourchman, Professor, University of Louisville
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleDoxycyclineAzithromycin
    Arm/Group DescriptionOral doxycycline doxycycline: Oral doxycycline 100mg bidTopical azithromycin daily to the conjunctival culdesac azithromycin: topical 1% azithromycin daily to eye
    Period Title: Overall Study
    STARTED922
    COMPLETED917
    NOT COMPLETED05

    Baseline Characteristics

    Arm/Group TitleDoxycyclineAzithromycinTotal
    Arm/Group DescriptionOral doxycycline doxycycline: Oral doxycycline 100mg bidTopical azithromycin daily to the conjunctival culdesac azithromycin: topical 1% azithromycin daily to eyeTotal of all reporting groups
    Overall Participants92231
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    68
    (4)
    64
    (3)
    65
    (3)
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    10
    45.5%
    10
    32.3%
    Male
    9
    100%
    12
    54.5%
    21
    67.7%
    Region of Enrollment (participants) [Number]
    United States
    9
    100%
    22
    100%
    31
    100%

    Outcome Measures

    1. Primary Outcome
    TitleGlobal Response to Therapy
    DescriptionGlobal 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.
    Time Frame4 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleDoxycyclineAzithromycin
    Arm/Group DescriptionOral doxycycline doxycycline: Oral doxycycline 100mg bidTopical azithromycin daily to the conjunctival culdesac azithromycin: topical 1% azithromycin daily to eye
    Measure Participants922
    Measure eyes1844
    Number [eyes]
    16
    41
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Doxycycline, Azithromycin
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value.001
    Comments
    Methodt-test, 2 sided
    Comments

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group TitleDoxycyclineAzithromycin
    Arm/Group DescriptionOral doxycycline doxycycline: Oral doxycycline 100mg bidTopical azithromycin daily to the conjunctival culdesac azithromycin: topical 1% azithromycin daily to eye
    All Cause Mortality
    DoxycyclineAzithromycin
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/9 (0%) 0/22 (0%)
    Serious Adverse Events
    DoxycyclineAzithromycin
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/9 (0%) 0/22 (0%)
    Other (Not Including Serious) Adverse Events
    DoxycyclineAzithromycin
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/9 (0%) 0/22 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitleProfessor Douglas Borchman
    OrganizationUniversity of Louisville
    Phone502 852 7435
    Emailborchman@louisville.edu
    Responsible Party:
    Douglas Bourchman, Professor, University of Louisville
    ClinicalTrials.gov Identifier:
    NCT00803452
    Other Study ID Numbers:
    • lipidtearfilm
    • NEI RO-1- EY017094-02
    First Posted:
    Dec 5, 2008
    Last Update Posted:
    Dec 22, 2017
    Last Verified:
    Nov 1, 2017