Dry EyeNCT03116776
Walnut Shell Glasses Moxibustion for Dry Eye Syndrome
A study testing Walnut Shell Glasses Moxibustion and Sodium hyaluronate eye drops in people with Dry Eye, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 2 sites in China.
Trial summary
This trial is designed to evaluate the efficacy of walnut shell glasses moxibustion for dry eye syndrome compared with sodium hyaluronate eye drops. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dry Eye
- What is being tested?
- Walnut Shell Glasses Moxibustion and Sodium hyaluronate eye drops
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 2 sitesChina
- Study dates
- 1 May 2017to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Guang'anmen Hospital, China Academy of Chinese Medical Sceince
Beijing, Beijing Municipality, 100053
Weiwei Fu, +86-15201309895, fuweiwei_vm@163.com
Zhishun Liu, +86-10-88001124, liuzhishun@aliyun.com
- Recruiting
Guang'anmen Hospital, China Academy of Chinese Medical Science
Beijing, Beijing Municipality, 100053
Weiwei Fu, +86-15201309895, fuweiwei_vm@163.com
Zhishun Liu, +86-10-88001124, liuzhishun@aliyun.com
About this study
Official title: 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.
- Conditions
- Dry Eye
- Being tested
- Walnut Shell Glasses Moxibustion, Sodium hyaluronate eye drops
- Keywords
- walnut shell glasses moxibustion, dry eye, randomized controlled trial
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walnut Shell Glasses MoxibustionProcedure or surgery
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.
Sodium hyaluronate eye dropsDrug
One drop for each eye, four times per day for over 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Walnut Shell Glasses Moxibustion |
| Sodium hyaluronate eye drops | Active comparator | Commonly used artificial tears in clinical. Receives: Drug: Sodium hyaluronate eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 4, week 16, week 28
Secondary outcomes (8)
the efficacy of Walnut Shell Glasses Moxibustion
The proportion of patients whose OSDI score reduced more than 50%
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 .
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start1 May 2017
- Primary completion30 Jul 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiwei Fu, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Weiwei Fu, Principal investigator, Department of Acupuncture, Guang' anmen hospital，China Academy of Chinese Medical Science, Beijing(100053), China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116776
- Sponsor's protocol ID
- 2016-121-KY-01
- Status last verified
- Jul 2018
- First submitted
- 12 Apr 2017
- Last updated
- 9 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walnut Shell Glasses Moxibustion for Dry Eye Syndrome: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03116776
- Acronym / sponsor ID
- 2016-121-KY-01
- Conditions
- Dry Eye
- Keywords
- walnut shell glasses moxibustion, dry eye, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Jul 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 17 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is designed to evaluate the efficacy of walnut shell glasses moxibustion for dry eye syndrome compared with sodium hyaluronate eye drops.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walnut Shell Glasses Moxibustion | Experimental | Procedure: Walnut Shell Glasses MoxibustionUse 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. |
| Sodium hyaluronate eye drops | Active comparator | Drug: Sodium hyaluronate eye dropsCommonly used artificial tears in clinical. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walnut Shell Glasses MoxibustionParticipants 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. | Procedure or surgery | Walnut Shell Glasses Moxibustion |
| Sodium hyaluronate eye dropsOne drop for each eye, four times per day for over 4 weeks. | Drug | Sodium hyaluronate eye drops |
Primary outcome
change from baseline in OSDI score
Time frame: week 4, week 16, week 28
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.
8 secondary outcomes
the efficacy of Walnut Shell Glasses Moxibustion
Time frame: week 4, week 16, week 28
change from baseline in mean weekly OSDI score
Time frame: week 1-4, week 16, week 28
change from baseline in VAS of eye discomfort
Time frame: week 4, week 16, week 28
change from baseline in mean daily VAS score
Time frame: week 1-4, week 16, week 28
change from baseline in BUT
Time frame: week 2, week 4
change from baseline in SchimerⅠtext
Time frame: week 2, week 4
change from baseline in corneal fluorescence staining scores
Time frame: week 2, week 4
patiant's expectations for moxibustion
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2018.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weiwei Fu principal investigator
Department of Acupuncture, Guang' anmen hospital，China Academy of Chinese Medical Science, Beijing(100053), China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walnut Shell Glasses Moxibustion and Sodium hyaluronate eye drops in people with Dry Eye, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weiwei Fu (+86-15201309895, fuweiwei_vm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in OSDI score (time frame: week 4, week 16, week 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2018.