Effect of Behavioral Intervention (Baduanjin Alone or Laughter Exercise Plus Artificial Tears) Versus Artificial Tear on Dry Eye Disease: a Randomised Controlled Trial

NCT07524725 | Not Yet Recruiting

• 1 other identifier: 2026LSPJ089
• Study Type: interventional
• Target: 540
• Locations: 0 countries
• Sites: N/A

Brief 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. The main questions it aims to answer are:

• 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)

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  From baseline to the end of interventions at week 12

• Change in OSDI score at week 48

  From baseline to weeks 16, 24, 36, and 48.

• Change in non-invasive tear film break up time at week 12

  From baseline to weeks 4, 8, and 12

• Change in non-invasive tear film break up time at week 48

  From baseline to weeks 16, 24, 36, and 48

• Change in tear meniscus height at week 12

  From baseline to weeks 4, 8, and 12

Other Outcomes (24)

• Change in blood pressure at week 12

  From baseline to weeks 4, 8, and 12

• Change in blood pressure at week 48

  From baseline to weeks 16, 24, 36, and 48

• Change in heart rate at week 12

  From baseline to weeks 4, 8, and 12

Study Arms (3)

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.

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.

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.

Drug: Artificial tears

Interventions

Baduanjin BEHAVIORAL

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.

Baduanjin alone

Laughter exercise BEHAVIORAL

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

Laughter exercise plus artificial tears

Artificial tears DRUG

Participants use 0.1% sodium hyaluronate eye drops 4 times per day in both eyes.

Artificial tears; Laughter exercise plus artificial tears

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Central Study Contacts

Lingyi Liang

CONTACT

13829738319; lianglingyi@gzzoc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor; Vice President of Zhongshan Ophthalmic Center, Head of the Preventive Ophthalmology Department

Study Record Dates

• First Submitted: April 5, 2026
• First Posted: April 13, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2033
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share