NCT03116776

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 17, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

July 9, 2018

Status Verified

July 1, 2018

Enrollment Period

1.2 years

First QC Date

April 12, 2017

Last Update Submit

July 6, 2018

Conditions

Dry Eye

Keywords

walnut shell glasses moxibustiondry eyerandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • the efficacy of Walnut Shell Glasses Moxibustion

    week 4, week 16, week 28

  • change from baseline in mean weekly OSDI score

    week 1-4, week 16, week 28

  • change from baseline in VAS of eye discomfort

    week 4, week 16, week 28

  • change from baseline in mean daily VAS score

    week 1-4, week 16, week 28

  • change from baseline in BUT

    week 2, week 4

  • +3 more secondary outcomes

Study Arms (2)

Walnut Shell Glasses Moxibustion

EXPERIMENTAL

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

Sodium hyaluronate eye drops

ACTIVE COMPARATOR

Commonly used artificial tears in clinical.

Drug: Sodium hyaluronate eye drops

Interventions

Walnut Shell Glasses MoxibustionPROCEDURE

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.

Walnut Shell Glasses Moxibustion
Sodium hyaluronate eye dropsDRUG

One drop for each eye, four times per day for over 4 weeks.

Sodium hyaluronate eye drops

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Guang'anmen Hospital, China Academy of Chinese Medical Sceince

Beijing, Beijing Municipality, 100053, China

RECRUITING

Guang'anmen Hospital, China Academy of Chinese Medical Science

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Weiwei Fu

    Department of Acupuncture, Guang' anmen hospital，China Academy of Chinese Medical Science, Beijing(100053), China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weiwei Fu

CONTACT

+86-15201309895fuweiwei_vm@163.com

Zhishun Liu

CONTACT

+86-10-88001124liuzhishun@aliyun.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
outcome assessor and statistician will be blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate

Study Record Dates

First Submitted

April 12, 2017

First Posted

April 17, 2017

Study Start

May 1, 2017

Primary Completion

July 30, 2018

Study Completion

December 30, 2018

Last Updated

July 9, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will share

Locations

CN(2)