Back to resultsEfficacy 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
About this trial
This is an interventional treatment trial for Dry Eye Syndrome focused on measuring IPL, MGD
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
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
NCT ID
NCT02958514
First Posted
October 3, 2016
Last Updated
May 1, 2022
Sponsor
Peking University Third Hospital
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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