Walnut Shell Glasses Moxibustion for Dry Eye Syndrome

Walnut Shell Glasses Moxibustion for Dry Eye Syndrome: a Randomized Controlled Trial

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

Study Overview

• Status: Unknown
• Conditions: Dry Eye
• Intervention / Treatment: Procedure: Walnut Shell Glasses Moxibustion; Drug: Sodium hyaluronate eye drops

• Study Type: Interventional
• Enrollment (Anticipated): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Guang'anmen Hospital, China Academy of Chinese Medical Sceince
      • Contact: Zhishun Liu; Phone Number: +86-10-88001124; Email: liuzhishun@aliyun.com
      • Contact: Weiwei Fu; Phone Number: +86-15201309895; Email: fuweiwei_vm@163.com
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Guang'anmen Hospital, China Academy of Chinese Medical Science
      • Contact: Zhishun Liu; Phone Number: +86-10-88001124; Email: liuzhishun@aliyun.com
      • Contact: Weiwei Fu; Phone Number: +86-15201309895; Email: fuweiwei_vm@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Walnut Shell Glasses Moxibustion; 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.	Procedure: Walnut Shell Glasses Moxibustion; 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.
Active Comparator: Sodium hyaluronate eye drops; Commonly used artificial tears in clinical.	Drug: Sodium hyaluronate eye drops; One drop for each eye, four times per day for over 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	week 4, week 16, week 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the efficacy of Walnut Shell Glasses Moxibustion	The proportion of patients whose OSDI score reduced more than 50%	week 4, week 16, week 28
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.	week 1-4, week 16, week 28
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).	week 4, week 16, week 28
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.	week 1-4, week 16, week 28
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.	week 2, week 4
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.	week 2, week 4
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.	week 2, week 4
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 .	baseline

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Investigators: Principal Investigator: Weiwei Fu, Department of Acupuncture, Guang' anmen hospital，China Academy of Chinese Medical Science, Beijing(100053), China

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Anticipated): July 30, 2018
• Study Completion (Anticipated): December 30, 2018

Study Registration Dates

• First Submitted: April 12, 2017
• First Submitted That Met QC Criteria: April 14, 2017
• First Posted (Actual): April 17, 2017

Study Record Updates

• Last Update Posted (Actual): July 9, 2018
• Last Update Submitted That Met QC Criteria: July 6, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: randomized controlled trial; dry eye; walnut shell glasses moxibustion
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Pharmaceutical Solutions; Viscosupplements; Ophthalmic Solutions; Hyaluronic Acid
• Other Study ID Numbers: 2016-121-KY-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No