Dry Eye Disease (DED)NCT07524725
Effect of Behavioral Intervention (Baduanjin Alone or Laughter Exercise Plus Artificial Tears) Versus Artificial Tear on Dry Eye Disease: a Randomised Controlled Trial
A study testing Baduanjin, Laughter exercise and Artificial tears in people with Dry Eye Disease (DED), run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
Trial summary
The goal of this clinical trial is to compare the effect of behavioral intervention (Baduanjin alone or laughter exercise plus artificial tears) versus artificial tears in patients with dry eye disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dry Eye Disease (DED)
- What is being tested?
- Baduanjin, Laughter exercise and Artificial tears
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 31 Dec 2033
- Phase
- Interventional
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 TO ≤45 years of age, any sex.
- Meet the dry eye diagnostic criteria of the DEWS international consensus, and show both of the following two conditions: OSDI score between 18 and 80; NIBUT (Non-invasive tear break-up time) < 8 seconds
- Best corrected visual acuity ≥ 0.5(10/20) (in each eye).
- Intraocular pressure between 5 and 21 mmHg (in each eye).
- Women of childbearing potential must agree to use safe contraception during the study.
- Willingness/ability to return for all study visits and to follow instructions from the study investigator and their staff.
- Voluntary participation and signing of the informed consent form approved by the Ethics Committee.
Who cannot join
- NEI corneal fluorescein staining score > 5 (in either eye).
- Wore contact lenses within the past 14 days and cannot commit to not wearing them during the study period (3 months) (in either eye).
- Received refractive surgery (LASIK, SMILE) or other ocular surgery, or had ocular trauma within the past 12 months (in either eye).
- Had acute allergic conjunctivitis, infection, or ocular surface inflammation within the past 3 months (in either eye).
- Eyelid abnormalities that affect eyelid function, such as nystagmus, blepharospasm, ectropion, entropion, or severe trichiasis (in either eye).
- Previously diagnosed with glaucoma and received medical or surgical treatment (in either eye).
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- Currently receiving other ophthalmic or systemic treatments that may affect the tear film.
- Allergy to fluorescein sodium.
- Have a serious health condition that may limit their ability to participate.
- Pregnant, breastfeeding, or planning to become pregnant.
- Diagnosed with neurological or psychiatric disorders (e.g., severe anxiety, depression, or severe sleep disorder).
- Have difficulty with physical movement.
- Previous experience with traditional exercise such as Baduanjin.
- Previous experience with laughter exercise.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to compare the effect of behavioral intervention (Baduanjin alone or laughter exercise plus artificial tears) versus artificial tears in patients with dry eye disease.
The main questions it aims to answer are:
Read more
- Does the Baduanjin improve the Ocular Surface Disease Index score of patients with dry eye disease?
- Does the laughter exercise plus artificial tears improve the Ocular Surface Disease Index score of patients with dry eye disease?
Researchers will compare behavioral intervention (Baduanjin alone or laughter exercise plus artificial tears) versus artificial tears to see if behavioral intervention works to treat dry eye disease.
Participants will：
- Do the Baduanjin 5 times per week, or do laughter exercise plus artifical tears 4 times per day, or use artificial tears alone 4 times per day for 12 weeks
- Visit the clinic once right before the intervention and the 4, 8, 12, 16, 24, 36, and 48 weeks after starting the intervention for checkups and tests
- Use the app developed by our study to record the behavioral intervention and/or use of eye drops.
- Conditions
- Dry Eye Disease (DED)
- Being tested
- Baduanjin, Laughter exercise, Artificial tears
- 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.
BaduanjinBehavioural
Participants perform Baduanjin 5 times per week for 12 weeks. The standardized version, endorsed by the General Administration of Sport of China, includes 8 movements performed for 10 to 15 minutes.
Laughter exerciseBehavioural
Launch the "smile face recognition" APP on smart phone, after user guidance and pretest, a smile exercise will display on the phone, while facing the front camera on the phone, participant will do an exercise emphasizing facial movements, as exaggerated as possible. The exercise last for 12 weeks and 4 times a day
Artificial tearsDrug
Participants use 0.1% sodium hyaluronate eye drops 4 times per day in both eyes.
| Study group | Role | What they receive |
|---|---|---|
| Baduanjin alone | Experimental | Perform Baduanjin 5 times per week for 12 weeks. During the first 4 weeks, participants will practice with a coach in person once per week. The remaining sessions will be done by following a video or live online class. Each session lasts 24 minutes. Receives: Behavioral: Baduanjin |
| Laughter exercise plus artificial tears | Experimental | Perform laughter exercise 4 times per day and use 0.1% sodium hyaluronate eye drops in both eyes 4 times per day. Receives: Behavioral: Laughter exercise; Drug: Artificial tears |
| Artificial tears | Active comparator | Use 0.1% sodium hyaluronate eye drops in both eyes 4 times per day for 12 weeks. Receives: Drug: Artificial tears |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of OSDI scores at week 12
The OSDI is a 12-item patient-reported outcomes questionnaire designed by a staff of a pharmaceutical company (Allergan, Inc.) to provide a rapid assessment of the range of ocular surface symptoms, including symptoms related to chronic dry eye, their severity, and their impact on the patient's ability to function. In addition to an overall score, there are three subscales of the OSDI: ocular symptoms, vision-related function, and environmental triggers. The OSDI score is calculated as: (total points from all answers × 100) / (number of answered questions × 4). A higher score indicates worse symptoms.
Measured: From baseline to weeks 1, 2, 4, 6, 8, 10, and 12
Secondary outcomes (20)
Proportion of patients with 10 points or more decreased in OSDI at week 12
The proportion of patients with a decrease from baseline in the ocular surface disease index score (OSDI) of 10 points or more (the minimal clinically meaningful cut-off)
Measured: From baseline to the end of interventions at week 12
Change in OSDI score at week 48
OSDI scores change from baseline to week 48.
Measured: From baseline to weeks 16, 24, 36, and 48.
Change in non-invasive tear film break up time at week 12
Non-invasive tear break-up time (NIBUT), measured using a keratograph (Keratograph 5M). Participants blink twice, then the time to first dry spot on the cornea is recorded using Placido disk principle. The average of three measurements is used.
Measured: From baseline to weeks 4, 8, and 12
Change in non-invasive tear film break up time at week 48
Non-invasive tear break-up time (NIBUT), measured using a keratograph (Keratograph 5M). Participants blink twice, then the time to first dry spot on the cornea is recorded using Placido disk principle. The average of three measurements is used.
Measured: From baseline to weeks 16, 24, 36, and 48
Change in tear meniscus height at week 12
Tear meniscus height, measured using a keratograph (Keratograph 5M) as the vertical height of the tear fluid just below the pupil margin, reflecting tear secretion volume.
Measured: From baseline to weeks 4, 8, and 12
Change in tear meniscus height at week 48
Tear meniscus height, measured using a keratograph (Keratograph 5M) as the vertical height of the tear fluid just below the pupil margin, reflecting tear secretion volume.
Measured: From enrollment to the weeks 16, 24, 36, and 48
Change in corneal fluorescein staining score at week 12
Corneal fluorescein staining score (NIH scale, 0-15). The cornea is divided into 5 regions, each scored 0-3 based on the number of staining dots, for a total score of 0 to 15.
Measured: From baseline to weeks 4, 8, and 12
Change in corneal fluorescein staining score at week 48
Corneal fluorescein staining score (NIH scale, 0-15). The cornea is divided into 5 regions, each scored 0-3 based on the number of staining dots, for a total score of 0 to 15.
Measured: From baseline to weeks 16, 24, 36, and 48
Change in lipid layer thickness at week 12
Lipid layer thickness, measured automatically using a Lipiview interferometer.
Measured: From baseline to weeks 4, 8, and 12
Change in lipid layer thickness at week 48
Lipid layer thickness, measured automatically using a Lipiview interferometer.
Measured: From baseline to weeks 16, 24, 36, and 48
Change in Self-Rating Anxiety Scale at week 12
The Self-Rating Anxiety Scale consists of 20 items related to anxiety symptoms. It assesses the severity of anxiety over the past week across dimensions such as subjective anxiety feelings, autonomic nervous system disturbances, and motor tension. The raw score is the sum of all item scores, which is then converted to a standardized score ranging from 0 to 100. Higher scores indicate more severe anxiety.
Measured: From baseline to weeks 4, 8, and 12
Change in Self-Rating Anxiety Scale at week 48
The Self-Rating Anxiety Scale consists of 20 items related to anxiety symptoms. It assesses the severity of anxiety over the past week across dimensions such as subjective anxiety feelings, autonomic nervous system disturbances, and motor tension. The raw score is the sum of all item scores, which is then converted to a standardized score ranging from 0 to 100. Higher scores indicate more severe anxiety.
Measured: From baseline to weeks 16, 24, 36, and 48
Change in Self-Rating Depression Scale at week 12
The Self-Rating Depression Scale consists of 20 items related to depressive symptoms. It assesses the severity of depression over the past week across core dimensions including low mood, slowed thinking, somatic symptoms (e.g., sleep disturbances, loss of appetite), and reduced volitional activity. The raw score is the sum of all item scores, which is then converted to a standardized score ranging from 0 to 100. Higher scores indicate more severe depression.
Measured: From baseline to weeks 4, 8, and 12
Change in Self-Rating Depression Scale at week 48
The Self-Rating Depression Scale consists of 20 items related to depressive symptoms. It assesses the severity of depression over the past week across core dimensions including low mood, slowed thinking, somatic symptoms (e.g., sleep disturbances, loss of appetite), and reduced volitional activity. The raw score is the sum of all item scores, which is then converted to a standardized score ranging from 0 to 100. Higher scores indicate more severe depression.
Measured: From baseline to weeks 16, 24, 36, and 48
Change in Subjective Happiness Scale at week 12
The Subjective Happiness Scale consists of 4 items measuring subjective well-being, covering life satisfaction, positive emotional experiences, and frequency of negative emotions. The total score is the average of the item scores, ranging from 0 to 7. Higher scores indicate a higher level of subjective happiness.
Measured: From baseline to weeks 4, 8, and 12
Change in Subjective Happiness Scale at week 48
The Subjective Happiness Scale consists of 4 items measuring subjective well-being, covering life satisfaction, positive emotional experiences, and frequency of negative emotions. The total score is the average of the item scores, ranging from 0 to 7. Higher scores indicate a higher level of subjective happiness.
Measured: From baseline to weeks 16, 24, 36, and 48
Change in Pittsburgh Sleep Quality Index at week 12
The Pittsburgh Sleep Quality Index consists of 15 items assessing sleep quality over the past month across 7 dimensions: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The component scores are summed to give a global score ranging from 0 to 21. Higher scores indicate worse sleep quality.
Measured: From baseline to weeks 4, 8, and 12
Change in Pittsburgh Sleep Quality Index at week 48
The Pittsburgh Sleep Quality Index consists of 15 items assessing sleep quality over the past month across 7 dimensions: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The component scores are summed to give a global score ranging from 0 to 21. Higher scores indicate worse sleep quality.
Measured: From baseline to weeks 16, 24, 36, and 48
Change in SF-36 Scale at week 12
The 36-Item Short Form Health Survey (SF-36) consists of 36 items measuring health-related quality of life across 8 dimensions: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Each dimension score is standardized to a range of 0 to 100. Higher scores indicate better health status in that dimension.
Measured: From baseline to weeks 4, 8, and 12
Change in SF-36 Scale at week 48
The 36-Item Short Form Health Survey (SF-36) consists of 36 items measuring health-related quality of life across 8 dimensions: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Each dimension score is standardized to a range of 0 to 100. Higher scores indicate better health status in that dimension.
Measured: From baseline to weeks 16, 24, 36, and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease (DED)Studies 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
- Outcomes assessor
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lingyi Liang, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524725
- Sponsor's protocol ID
- 2026LSPJ089
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No