Dry EyeNCT06720428
Acupoint Therapy Device for Dry Eye
A study testing dry eye acupoint therapy instrument and Artificial tear in people with Dry Eye, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
To built a dry eye acupoint therapeutic instrument by stimulating acupoints with low impulse current .And the safety of the dry eye acupoint treatment device will be tested and the initial validation will be verified. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- dry eye acupoint therapy instrument and Artificial tear
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 May 2024
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who meet the diagnostic criteria for dry eye: The diagnostic and classification criteria refer to the Consensus of Chinese dry eye Experts: Definition and Classification (2020);
- this study included patients with dry eyes can be treated as usual or are using artificial tears, also can be never accepted artificial tears treatment;
- this research project, informed consent and signed informed consent form, participants are willing to accept treatment.
- Those who met the above criteria could be included in the study.
Who cannot join
- Patients with other eye diseases, acute inflammation or allergy of the eye or skin around the eye: such as blepharitis, lacrimal duct obstruction, congenital absence or dysplasia of lacrimal gland, anterior ganglia inflammation, such as trachoma, chemical burn and other corneal and conjunctival lesions, extensive scar of the eyelid conjunctival, long-term use of anti-glaucoma eye drops for glaucoma;
- Those who have undergone external or internal eye surgery in the past 6 months；
- Patients who have undergone tear punctum embolization or submandibular gland transplantation;
- Wearing contact lenses within the past 3 months； （5）History of ocular trauma; （6）Active fundus lesions in the past 3 months； （7）People who are allergic to artificial tears; （8）Suffering from diseases that affect tear secretion, such as facial paralysis, diabetes, and hyperthyroidism;
- (9)Patients with serious life-threatening primary diseases such as cardiovascular, cerebrovascular, liver, kidney, and hematopoietic system diseases, as well as mental illness; (10)Attending other clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 270002
About this study
Official title: Development of a Prototype of Acupoint Therapy Device for Dry Eye and Preliminary Verification of Its Clinical Efficacy
To built a dry eye acupoint therapeutic instrument by stimulating acupoints with low impulse current .And the safety of the dry eye acupoint treatment device will be tested and the initial validation will be verified.
- Conditions
- Dry Eye
- Being tested
- dry eye acupoint therapy instrument, Artificial tear
- Keywords
- Acupuncture treatment, Dry Eye Acupoint Therapeutic Instrument, Safety, Validity
- 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.
dry eye acupoint therapy instrumentDevice
The dry eye acupuncture point treatment device treat dry eye through stimulating acupuncture points by low pulse current.
Artificial tearDrug
0.3% Ali eye drops
| Study group | Role | What they receive |
|---|---|---|
| Dry eye acupoint therapy instrument treatment group One | Experimental | Dry eye acupoint therapy instrument treatment group One was treated with instrument twice a week, at least two day apart, each time lasting 30 minutes. Treatment points include Jingming, Cunzhu, Si Zhukong , Sun , Sibai and Chengqi. Receives: Device: dry eye acupoint therapy instrument; Drug: Artificial tear |
| Dry eye acupoint therapy instrument treatment group Two | Experimental | Dry eye acupoint therapy instrument treatment group Two had the same treatment method with different treatment parameters. Receives: Device: dry eye acupoint therapy instrument; Drug: Artificial tear |
| Artificial tear treatment group | Active comparator | The artificial tear treatment group was treated with artificial tear (Ali eye drops) four times a day. Receives: Drug: Artificial tear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Schirmer's test (SLT)
The Schirmer test uses filter paper to wick up tears and measure the amount of production.
Measured: baseline and 8 weeks post-treatment
Tear film breakup time (TBUT)
The time interval between keeping eyes open after blinking until the first dry spot appears on the tear film surface is one of the important criteria to evaluate the stability of tear film.
Measured: baseline and 8 weeks post-treatment
Ocular Surface Disease Index, OSDI
The most commonly used questionnaire in clinical diagnosis of dry eye. It is mainly used to diagnose dry eye and assess the severity of the condition
Measured: baseline and 8 weeks post-treatment
Corneal fluorescein staining (CFS)
Corneal fluorescein staining (CFS) is a valuable clinical tool to assess the viability of the epithelium.
Measured: baseline and 8 weeks post-treatment
Secondary outcomes (1)
MGD
Meibomian Gland (MG) expressibility and secretion quality
Measured: baseline and 8 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start1 Jan 2021
- Primary completion31 May 2024
- Study completion31 May 2024
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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Yu, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720428
- Sponsor's protocol ID
- YNCR2B003
- Status last verified
- Dec 2024
- First submitted
- 28 Aug 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Prototype of Acupoint Therapy Device for Dry Eye and Preliminary Verification of Its Clinical Efficacy
- ClinicalTrials.gov ID
- NCT06720428
- Acronym / sponsor ID
- YNCR2B003
- Conditions
- Dry Eye
- Keywords
- Acupuncture treatment, Dry Eye Acupoint Therapeutic Instrument, Safety, Validity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 6 Dec 2024 (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.
To built a dry eye acupoint therapeutic instrument by stimulating acupoints with low impulse current .And the safety of the dry eye acupoint treatment device will be tested and the initial validation will be verified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dry eye acupoint therapy instrument treatment group One | Experimental | Device: dry eye acupoint therapy instrument, Drug: Artificial tearDry eye acupoint therapy instrument treatment group One was treated with instrument twice a week, at least two day apart, each time lasting 30 minutes. Treatment points include Jingming, Cunzhu, Si Zhukong , Sun , Sibai and Chengqi. |
| Dry eye acupoint therapy instrument treatment group Two | Experimental | Device: dry eye acupoint therapy instrument, Drug: Artificial tearDry eye acupoint therapy instrument treatment group Two had the same treatment method with different treatment parameters. |
| Artificial tear treatment group | Active comparator | Drug: Artificial tearThe artificial tear treatment group was treated with artificial tear (Ali eye drops) four times a day. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who meet the diagnostic criteria for dry eye: The diagnostic and classification criteria refer to the Consensus of Chinese dry eye Experts: Definition and Classification (2020);
- this study included patients with dry eyes can be treated as usual or are using artificial tears, also can be never accepted artificial tears treatment;
- this research project, informed consent and signed informed consent form, participants are willing to accept treatment.
- Those who met the above criteria could be included in the study.
Key exclusion criteria (5 listed)
- Patients with other eye diseases, acute inflammation or allergy of the eye or skin around the eye: such as blepharitis, lacrimal duct obstruction, congenital absence or dysplasia of lacrimal gland, anterior ganglia inflammation, such as trachoma, chemical burn and other corneal and conjunctival lesions, extensive scar of the eyelid conjunctival, long-term use of anti-glaucoma eye drops for glaucoma;
- Those who have undergone external or internal eye surgery in the past 6 months；
- Patients who have undergone tear punctum embolization or submandibular gland transplantation;
- Wearing contact lenses within the past 3 months； （5）History of ocular trauma; （6）Active fundus lesions in the past 3 months； （7）People who are allergic to artificial tears; （8）Suffering from diseases that affect tear secretion, such as facial paralysis, diabetes, and hyperthyroidism;
- (9)Patients with serious life-threatening primary diseases such as cardiovascular, cerebrovascular, liver, kidney, and hematopoietic system diseases, as well as mental illness; (10)Attending other clinical trials.
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 |
|---|---|---|
| dry eye acupoint therapy instrumentThe dry eye acupuncture point treatment device treat dry eye through stimulating acupuncture points by low pulse current. | Device | Dry eye acupoint therapy instrument treatment group One, Dry eye acupoint therapy instrument treatment group Two |
| Artificial tear0.3% Ali eye drops | Drug | Artificial tear treatment group, Dry eye acupoint therapy instrument treatment group One, Dry eye acupoint therapy instrument treatment group Two |
Primary outcome
Schirmer's test (SLT)
Time frame: baseline and 8 weeks post-treatment
The Schirmer test uses filter paper to wick up tears and measure the amount of production.
Tear film breakup time (TBUT)
Time frame: baseline and 8 weeks post-treatment
The time interval between keeping eyes open after blinking until the first dry spot appears on the tear film surface is one of the important criteria to evaluate the stability of tear film.
Ocular Surface Disease Index, OSDI
Time frame: baseline and 8 weeks post-treatment
The most commonly used questionnaire in clinical diagnosis of dry eye. It is mainly used to diagnose dry eye and assess the severity of the condition
Corneal fluorescein staining (CFS)
Time frame: baseline and 8 weeks post-treatment
Corneal fluorescein staining (CFS) is a valuable clinical tool to assess the viability of the epithelium.
1 secondary outcome
MGD
Time frame: baseline and 8 weeks post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dry eye acupoint therapy instrument and Artificial tear in people with Dry Eye, run by Shanghai 10th People's Hospital at 1 site 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Schirmer's test (SLT) (time frame: baseline and 8 weeks post-treatment). The study lists 4 primary outcomes in all. 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 6 Dec 2024.