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Walnut Shell Glasses Moxibustion for Dry Eye Syndrome

Primary Purpose

Dry Eye

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Walnut Shell Glasses Moxibustion
Sodium hyaluronate eye drops
Sponsored by
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring walnut shell glasses moxibustion, dry eye, randomized controlled trial

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. eyes are in line with dry eye diagnostic criteria.
  2. Age 18 to 75 years,
  3. signed informed consent, voluntary adherence to treatment for more than 1 month.

Exclusion Criteria:

  1. combined with other eye disease (such as conjunctiva, cornea and iris have significant lesions).
  2. eye surgery within 3 months.
  3. pregnant or lactating women.
  4. oral the drugs which could inhibit lacrimal gland secretion.
  5. severe meibomian gland dysfunction.
  6. severe eye burns, chemical injury patients.
  7. combined with cardiovascular and cerebrovascular, liver, kidney and hematopoietic system and other serious primary disease, mental patients.
  8. patients with Sjogren's syndrome.
  9. patients who are participating in other drug clinical trials.
  10. patients who are using other drugs or therapies for the treatment of dry eyes.

Sites / Locations

  • Guang'anmen Hospital, China Academy of Chinese Medical SceinceRecruiting
  • Guang'anmen Hospital, China Academy of Chinese Medical ScienceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Walnut Shell Glasses Moxibustion

Sodium hyaluronate eye drops

Arm Description

Use wire to make a glass frame which can fix two walnut shells and moxa roll in front of the eyes, the walnut shell should be soaked in medlar chrysanthemum water and use the moxibustion to treat eye disease.

Commonly used artificial tears in clinical.

Outcomes

Primary Outcome Measures

change from baseline in OSDI score
We use the ocular surface disease index(OSDI) to evaluate the degree of dry eye. Assessing time point: at week 4, week 16, week 28.

Secondary Outcome Measures

the efficacy of Walnut Shell Glasses Moxibustion
The proportion of patients whose OSDI score reduced more than 50%
change from baseline in mean weekly OSDI score
The mean weekly OSDI score over weeks 1-4 will be calculated as as the sum of each week divided by the number of weeks assessed.
change from baseline in VAS of eye discomfort
Eye discomfort VAS scale: for the eye symptoms of self-assessment. Dry eye symptoms include itching, foreign body sensation, burning sensation, pain, dry, blurred vision, photophobia, eye swelling, tear Crack，ect. The overall discomfort are evaluate by VAS . Uses a 100-mm line that is labeled at each end. 0 mm represents no eye discomfort, 100 mm represents the most intolerable eye discomfort. Patient will rate the VAS(average VAS in the past 24h three times a week).
change from baseline in mean daily VAS score
Patients will rate their average eye comfort with VAS three times a week. The mean daily VAS over week 1-4 will be calculated as the sum of each day divided by the number of days assessed.
change from baseline in BUT
Check the tear break time(BUT) should be carried out before the other steps in the operation of the eye, used to evaluate the stability of the tear film. In the room without air flow, 1% of the sodium fluorescein with a glass rod dipped in a little coating in the lower eyelid conjunctival sac, the patient after several times, through the slit lamp cobalt blue light wide band inspection tear film, with a stopwatch Record the last time after the completion of the first blink of an eye to open to the tear film appeared in the first randomly distributed dry spots or black lines of time, recorded three times to take the mean.
change from baseline in SchimerⅠtext
Evaluation the tear secretion, do not use ocular surface anesthetic, measuring the amount of reflex tear secretion. Place the test paper in the middle and outer 1/3 of the conjunctiva of the lower eyelid, and instruct the patient to lighten his eyes or look down at the bottom, and remove it after 5 minutes to measure the wetness from the beginning of the bend.
change from baseline in corneal fluorescence staining scores
Corneal fluorescein staining: 2% fluorescein sodium coated with glass rods in the conjunctival sac, observed under the slit lamp to observe whether the corneal epithelium with staining, such as yellow-green stained, suggesting that corneal epithelial cell integrity damage. Score by 12 points. Cornea was divided into 4 quadrants, each quadrant was 0-3, no staining was 0, 1 to 30 dotted was 1 point, > 30 dotted but not fused For 2 points, 3 points for the emergence of corneal punctate staining, filaments and ulcers.
patiant's expectations for moxibustion
This questionnaire includes three brief questions to investigate whether patients believe that moxibustion treatment will be useful. The relationship between patients' expectations and the effectiveness of moxibustion will be investigated because patients' beliefs about treatment enhanced or attenuated the effectiveness of treatment in a previous experimental study .

Full Information

First Posted
April 12, 2017
Last Updated
July 6, 2018
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03116776
Brief Title
Walnut Shell Glasses Moxibustion for Dry Eye Syndrome
Official Title
Walnut Shell Glasses Moxibustion for Dry Eye Syndrome: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
July 30, 2018 (Anticipated)
Study Completion Date
December 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This trial is designed to evaluate the efficacy of walnut shell glasses moxibustion for dry eye syndrome compared with sodium hyaluronate eye drops.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
walnut shell glasses moxibustion, dry eye, randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
outcome assessor and statistician will be blinded
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Walnut Shell Glasses Moxibustion
Arm Type
Experimental
Arm Description
Use wire to make a glass frame which can fix two walnut shells and moxa roll in front of the eyes, the walnut shell should be soaked in medlar chrysanthemum water and use the moxibustion to treat eye disease.
Arm Title
Sodium hyaluronate eye drops
Arm Type
Active Comparator
Arm Description
Commonly used artificial tears in clinical.
Intervention Type
Procedure
Intervention Name(s)
Walnut Shell Glasses Moxibustion
Intervention Description
Participants in experimental group will receive 12 sessions of walnut shell glasses moxibustion, each for 30 minutes,3 times per week, and administered over 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Sodium hyaluronate eye drops
Intervention Description
One drop for each eye, four times per day for over 4 weeks.
Primary Outcome Measure Information:
Title
change from baseline in OSDI score
Description
We use the ocular surface disease index(OSDI) to evaluate the degree of dry eye. Assessing time point: at week 4, week 16, week 28.
Time Frame
week 4, week 16, week 28
Secondary Outcome Measure Information:
Title
the efficacy of Walnut Shell Glasses Moxibustion
Description
The proportion of patients whose OSDI score reduced more than 50%
Time Frame
week 4, week 16, week 28
Title
change from baseline in mean weekly OSDI score
Description
The mean weekly OSDI score over weeks 1-4 will be calculated as as the sum of each week divided by the number of weeks assessed.
Time Frame
week 1-4, week 16, week 28
Title
change from baseline in VAS of eye discomfort
Description
Eye discomfort VAS scale: for the eye symptoms of self-assessment. Dry eye symptoms include itching, foreign body sensation, burning sensation, pain, dry, blurred vision, photophobia, eye swelling, tear Crack，ect. The overall discomfort are evaluate by VAS . Uses a 100-mm line that is labeled at each end. 0 mm represents no eye discomfort, 100 mm represents the most intolerable eye discomfort. Patient will rate the VAS(average VAS in the past 24h three times a week).
Time Frame
week 4, week 16, week 28
Title
change from baseline in mean daily VAS score
Description
Patients will rate their average eye comfort with VAS three times a week. The mean daily VAS over week 1-4 will be calculated as the sum of each day divided by the number of days assessed.
Time Frame
week 1-4, week 16, week 28
Title
change from baseline in BUT
Description
Check the tear break time(BUT) should be carried out before the other steps in the operation of the eye, used to evaluate the stability of the tear film. In the room without air flow, 1% of the sodium fluorescein with a glass rod dipped in a little coating in the lower eyelid conjunctival sac, the patient after several times, through the slit lamp cobalt blue light wide band inspection tear film, with a stopwatch Record the last time after the completion of the first blink of an eye to open to the tear film appeared in the first randomly distributed dry spots or black lines of time, recorded three times to take the mean.
Time Frame
week 2, week 4
Title
change from baseline in SchimerⅠtext
Description
Evaluation the tear secretion, do not use ocular surface anesthetic, measuring the amount of reflex tear secretion. Place the test paper in the middle and outer 1/3 of the conjunctiva of the lower eyelid, and instruct the patient to lighten his eyes or look down at the bottom, and remove it after 5 minutes to measure the wetness from the beginning of the bend.
Time Frame
week 2, week 4
Title
change from baseline in corneal fluorescence staining scores
Description
Corneal fluorescein staining: 2% fluorescein sodium coated with glass rods in the conjunctival sac, observed under the slit lamp to observe whether the corneal epithelium with staining, such as yellow-green stained, suggesting that corneal epithelial cell integrity damage. Score by 12 points. Cornea was divided into 4 quadrants, each quadrant was 0-3, no staining was 0, 1 to 30 dotted was 1 point, > 30 dotted but not fused For 2 points, 3 points for the emergence of corneal punctate staining, filaments and ulcers.
Time Frame
week 2, week 4
Title
patiant's expectations for moxibustion
Description
This questionnaire includes three brief questions to investigate whether patients believe that moxibustion treatment will be useful. The relationship between patients' expectations and the effectiveness of moxibustion will be investigated because patients' beliefs about treatment enhanced or attenuated the effectiveness of treatment in a previous experimental study .
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: eyes are in line with dry eye diagnostic criteria. Age 18 to 75 years, signed informed consent, voluntary adherence to treatment for more than 1 month. Exclusion Criteria: combined with other eye disease (such as conjunctiva, cornea and iris have significant lesions). eye surgery within 3 months. pregnant or lactating women. oral the drugs which could inhibit lacrimal gland secretion. severe meibomian gland dysfunction. severe eye burns, chemical injury patients. combined with cardiovascular and cerebrovascular, liver, kidney and hematopoietic system and other serious primary disease, mental patients. patients with Sjogren's syndrome. patients who are participating in other drug clinical trials. patients who are using other drugs or therapies for the treatment of dry eyes.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weiwei Fu
Phone
+86-15201309895
Email
fuweiwei_vm@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhishun Liu
Phone
+86-10-88001124
Email
liuzhishun@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weiwei Fu
Organizational Affiliation
Department of Acupuncture, Guang' anmen hospital，China Academy of Chinese Medical Science, Beijing(100053), China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guang'anmen Hospital, China Academy of Chinese Medical Sceince
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiwei Fu
Phone
+86-15201309895
Email
fuweiwei_vm@163.com
First Name & Middle Initial & Last Name & Degree
Zhishun Liu
Phone
+86-10-88001124
Email
liuzhishun@aliyun.com
Facility Name
Guang'anmen Hospital, China Academy of Chinese Medical Science
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiwei Fu
Phone
+86-15201309895
Email
fuweiwei_vm@163.com
First Name & Middle Initial & Last Name & Degree
Zhishun Liu
Phone
+86-10-88001124
Email
liuzhishun@aliyun.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Walnut Shell Glasses Moxibustion for Dry Eye Syndrome

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