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Efficacy Comparison of Two Kinds of Treatment in Treating Dry Eye Caused by Meibomian Gland Dysfunction

Primary Purpose

Dry Eye Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
intense pulsed light
Tobramycin and Dexamethasone Ophthalmic Ointment
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndrome focused on measuring IPL, MGD

Eligibility Criteria

26 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with dry eye syndrome and diagnosed as MGD

Exclusion Criteria:

  • an infection or inflammatory disease;
  • ocular surgical history with in the last 3 months
  • SGOGREN SYNDROME

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    traditional treatment group

    IPL treatment group

    Arm Description

    Subjects in this group are treated by tobramycin and dexamethasone ophthalmic ointment qn and artificial tears qid.

    Subjects in this group are treated with 3 cycles of intense pulsed light of 4 weeks interval and artificial tears qid.

    Outcomes

    Primary Outcome Measures

    Ocular Surface Disease Index (OSDI)
    normal value:<13 abnormal value:≥ 13

    Secondary Outcome Measures

    The concentrations of inflammatory cytokines such as IL-1、IL-6 and IL-8
    breakup time of tear film (BUT)
    normal value:>10s abnormal value:≤ 10s
    Corneal Fluorescein Stain(CFS)
    Eyelid ester discharge ability score
    Eyelid ester trait ratings

    Full Information

    First Posted
    October 3, 2016
    Last Updated
    May 1, 2022
    Sponsor
    Peking University Third Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02958514
    Brief Title
    Efficacy Comparison of Two Kinds of Treatment in Treating Dry Eye Caused by Meibomian Gland Dysfunction
    Official Title
    Efficacy Comparison of Two Kinds of Treatment in Treating Dry Eye Caused by Meibomian Gland Dysfunction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2016 (Actual)
    Primary Completion Date
    February 2017 (Actual)
    Study Completion Date
    March 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking University Third Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study aims to evaluate the efficacy of intense pulsed light in treating dry eye caused by meibomian gland dysfunction and make a comparison between the traditional treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dry Eye Syndrome
    Keywords
    IPL, MGD

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    traditional treatment group
    Arm Type
    Other
    Arm Description
    Subjects in this group are treated by tobramycin and dexamethasone ophthalmic ointment qn and artificial tears qid.
    Arm Title
    IPL treatment group
    Arm Type
    Experimental
    Arm Description
    Subjects in this group are treated with 3 cycles of intense pulsed light of 4 weeks interval and artificial tears qid.
    Intervention Type
    Device
    Intervention Name(s)
    intense pulsed light
    Intervention Description
    Intense pulse light (IPL) has been used in dermatology practices for several years as a treatment for rosacea and acne.IPL uses Xenon flashlamp to emit wavelengths of light from 400 to 1200nm. When placed on the light, a filter restricts the wavelength to the visible light range of *500nm.In 2007-2008, an IPL treatment technology-the Diamond Q4 by DermaMed Solutions-was specifically configured to our specifications with the goal of stimulating secretion of normal meibum via skin treatment effects on the meibomian glands. It was discovered that dry eye patients are better positioned for gland expression, as IPL seems to liquefy the abnormal viscous meibum and dilate the glands.
    Intervention Type
    Drug
    Intervention Name(s)
    Tobramycin and Dexamethasone Ophthalmic Ointment
    Primary Outcome Measure Information:
    Title
    Ocular Surface Disease Index (OSDI)
    Description
    normal value:<13 abnormal value:≥ 13
    Time Frame
    through study completion,an average of 6 months
    Secondary Outcome Measure Information:
    Title
    The concentrations of inflammatory cytokines such as IL-1、IL-6 and IL-8
    Time Frame
    through study completion,an average of 6 months
    Title
    breakup time of tear film (BUT)
    Description
    normal value:>10s abnormal value:≤ 10s
    Time Frame
    through study completion,an average of 6 months
    Title
    Corneal Fluorescein Stain(CFS)
    Time Frame
    through study completion,an average of 6 months
    Title
    Eyelid ester discharge ability score
    Time Frame
    through study completion,an average of 6 months
    Title
    Eyelid ester trait ratings
    Time Frame
    through study completion,an average of 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    26 Years
    Maximum Age & Unit of Time
    78 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with dry eye syndrome and diagnosed as MGD Exclusion Criteria: an infection or inflammatory disease; ocular surgical history with in the last 3 months SGOGREN SYNDROME

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Efficacy Comparison of Two Kinds of Treatment in Treating Dry Eye Caused by Meibomian Gland Dysfunction

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