Effect of Behavioral Intervention (Baduanjin Alone or Laughter Exercise Plus Artificial Tears) Ve… (NCT07524725) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of Behavioral Intervention (Baduanjin Alone or Laughter Exercise Plus Artificial Tears) Versus Artificial Tear on Dry Eye Disease: a Randomised Controlled Trial
540 participantsStarted 2027-01-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ≥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.
Exclusion Criteria:
* 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 te…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compares Baduanjin exercise and laughter exercise combined with artificial tears against artificial tears alone — how do these behavioral approaches fit with what you already recommend for my dry eye disease, and would trying them change anything about my current treatment plan?
2The trial hasn't started recruiting yet — given that my dry eye symptoms need attention now, would it make sense to start standard artificial tear therapy first while we wait to see if this study opens, or could delaying treatment cause any harm?
3The primary outcome is measured at 12 weeks using the OSDI questionnaire — how meaningful is a change in that score in real life, and would a 12-week commitment to structured exercise or laughter sessions be realistic given my schedule and lifestyle?
4Since this is a Phase NA behavioral study, what do we already know about the safety and effectiveness of Baduanjin or laughter exercise for dry eye, and is there any existing evidence my doctor finds convincing enough to guide my decision?
5If I were to discuss enrolling in this trial with my care team once it opens, what would disqualify me from participating, and are there any aspects of my health history that might make one of the three study groups — Baduanjin alone, laughter plus artificial tears, or artificial tears alone — a better or worse fit for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change of OSDI scores at week 12
Timeframe: From baseline to weeks 1, 2, 4, 6, 8, 10, and 12
Trial details
NCT IDNCT07524725
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University