Dry EyeNCT04668131
Study on Curative Effect and Mechanism of Acupuncture on Neuropathic Pain in Dry Eye Disease
A study testing Sodium hyaluronate eye drops and acupuncture in people with Dry Eye, run by Peking University Third Hospital at 2 sites in China.
Trial summary
This project is designed as a prospective, randomized, open, controlled clinical trial. For the first time, acupuncture was applied to the treatment of dry ocular neuropathic pain. Its mechanism was discussed by comparing the efficacy between acupuncture and artificial tears. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Dry Eye
- What is being tested?
- Sodium hyaluronate eye drops and acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- 22 Sep 2020to 30 Jun 2022
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- According to the DEWS diagnostic criteria, the OSDI score ≥ 13, with positive signs of dry eye (SIt ≤ 10mm/5min or TBUT ≤ 10s) or CFS positive;
- VAS>0;
- Signed informed consent.
Who cannot join
- Patients with dry eye who have had irritants directly irritating the ocular surface in the past 3 days;
- Eyeball infections, allergies, deformities, abnormal movements
- Any history of eye surgery
- Have had eye trauma or fundus laser treatment within 3 months
- Used drugs that affect tear production such as antihistamines, antidepressants, etc. within 30 days
- Suffer from systemic diseases that affect tear production, including Sjogren's syndrome, diabetes, mental illness, malignant tumors, etc.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Peking University Third Hospital
Beijing, 100191
About this study
This project is designed as a prospective, randomized, open, controlled clinical trial. For the first time, acupuncture was applied to the treatment of dry ocular neuropathic pain. Its mechanism was discussed by comparing the efficacy between acupuncture and artificial tears.
- Conditions
- Dry Eye
- Being tested
- Sodium hyaluronate eye drops, acupuncture
- Keywords
- dry eye, pain, acupuncture
- Medical subject headings
- Dry Eye Syndromes, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium hyaluronate eye dropsDrug
Also called artificial tears
eye drops, three times a day
acupunctureOther
three times a week
| Study group | Role | What they receive |
|---|---|---|
| Artificial tears | Experimental | Artificial tears Receives: Drug: Sodium hyaluronate eye drops |
| Acupuncture | Active comparator | Acupuncture Receives: Other: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Score
Ask the patient to mark the corresponding position on the ruler that can represent the pain or discomfort during the onset
Measured: The treatment period for each enrolled subject is one month
Secondary outcomes (6)
OSDI
OSDI consists of 12 scoring items, divided into three parts: severity of symptoms, impact of symptoms on daily life, and impact of environment on symptoms.
Measured: The treatment period for each enrolled subject is one month
TBUT
Drop 1 drop of 0.3% sodium fluorescein eye solution into the subject's conjunctival sac, dry it with a sterile cotton swab, and ask him to blink gently to make the fluorescein sodium evenly distributed. Observe the subject from the last time with a slit lamp cobalt blue light. The time from blinking to the first dark spot on the corneal surface, record three times and take the average
Measured: The treatment period for each enrolled subject is one month
SIt
Fold one end of the special 5mm×35mm filter paper (Tianjin Jingming) for tears by 5mm, and gently place it on the middle and outer 1/3 of the subject's lower eyelid conjunctival sac, and the other end will droop naturally. Ask the subject to gently close their eyes for 5 minutes After measuring the length of the filter paper wetted by tears
Measured: The treatment period for each enrolled subject is one month
CFS score
Divide the cornea into 5 quadrants (central + nose/temporal/upper/lower), each quadrant has a staining score of 0 to 3 points, and it is specified that no staining is 0 points, and 30 spots are stained as 1 point, and there is flaky staining and fusion 3 points for filament formation, 2 points between the two, the sum of 5 quadrants is the score of the entire cornea, and the CFS score of the entire cornea is 0-15 points.
Measured: The treatment period for each enrolled subject is one month
Density and curvature of corneal subbasal nerve
Collect corneal subbasal nerve images, 2 images each in the upper, lower, arm, temporal and central areas. Use deep learning methods to analyze nerve density and curvature
Measured: The treatment period for each enrolled subject is one month
Tear pain factor content
With the aid of a slit lamp, a capillary pipette was used to draw 5 μl tears/eye at the middle and outer edges of the lower eyelid 2/3 of the tear river, and placed in a low protein adhesion EP tube (containing 5 μl 1% BSA) and stored at -80°C. ELISA analyzes the protein levels of PGE2, substance P and NGF in tear fluid.
Measured: The treatment period for each enrolled subject is one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start22 Sep 2020
- Primary completion30 Mar 2022
- Study completion30 Jun 2022
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.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668131
- Sponsor's protocol ID
- 20200922
- Status last verified
- Sep 2020
- First submitted
- 6 Dec 2020
- Last updated
- 23 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Curative Effect and Mechanism of Acupuncture on Neuropathic Pain in Dry Eye Disease
- ClinicalTrials.gov ID
- NCT04668131
- Acronym / sponsor ID
- 20200922
- Conditions
- Dry Eye
- Keywords
- dry eye, pain, acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 16 Dec 2020 (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 project is designed as a prospective, randomized, open, controlled clinical trial. For the first time, acupuncture was applied to the treatment of dry ocular neuropathic pain. Its mechanism was discussed by comparing the efficacy between acupuncture and artificial tears.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artificial tears | Experimental | Drug: Sodium hyaluronate eye dropsArtificial tears |
| Acupuncture | Active comparator | Other: acupunctureAcupuncture |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- According to the DEWS diagnostic criteria, the OSDI score ≥ 13, with positive signs of dry eye (SIt ≤ 10mm/5min or TBUT ≤ 10s) or CFS positive;
- VAS>0;
- Signed informed consent.
Key exclusion criteria (6 listed)
- Patients with dry eye who have had irritants directly irritating the ocular surface in the past 3 days;
- Eyeball infections, allergies, deformities, abnormal movements
- Any history of eye surgery
- Have had eye trauma or fundus laser treatment within 3 months
- Used drugs that affect tear production such as antihistamines, antidepressants, etc. within 30 days
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 |
|---|---|---|
| Sodium hyaluronate eye dropsAlso: artificial tearseye drops, three times a day | Drug | Artificial tears |
| acupuncturethree times a week | Other | Acupuncture |
Primary outcome
Visual Analogue Score
Time frame: The treatment period for each enrolled subject is one month
Ask the patient to mark the corresponding position on the ruler that can represent the pain or discomfort during the onset
6 secondary outcomes
OSDI
Time frame: The treatment period for each enrolled subject is one month
TBUT
Time frame: The treatment period for each enrolled subject is one month
SIt
Time frame: The treatment period for each enrolled subject is one month
CFS score
Time frame: The treatment period for each enrolled subject is one month
Density and curvature of corneal subbasal nerve
Time frame: The treatment period for each enrolled subject is one month
Tear pain factor content
Time frame: The treatment period for each enrolled subject is one month
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 23 Nov 2022.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium hyaluronate eye drops and acupuncture in people with Dry Eye, run by Peking University Third Hospital 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 6 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 23 Nov 2022. 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?
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?
Visual Analogue Score (time frame: The treatment period for each enrolled subject is one month). 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 23 Nov 2022.