Dry Eye Disease
Conditions
Interventions
Mindfulness Meditation Group:During the first 8 weeks, participants were required to sequentially listen to specific mindfulness meditation audio programs on the Himalaya APP, including:
*"21-Day Min
0.1% Sodium Hyaluronate Eye Drops Group:For the first 8 weeks, participants were required to administer 0.1% sodium hyaluronate eye drops daily according to the following protocol:
Dosage & Administr
Sponsors
Eye Hospital, Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Participants must be at least 18 to 45 years old (inclusive) at the time of informed consent; 2. Meet the diagnostic criteria of dry eye syndrome of TFOS during screening; And showed the following two signs in the same eye. a. Ocular surface disease index (OSDI) score :13-80, b. non-invasive tear break-up time (NIBUT)=3.7; 4. Women of childbearing age had to meet the following conditions: have not been diagnosed with pregnancy before screening, agree to use a medically approved contraceptive method from the screening period to 30 days after the last intervention; 5. The subjects understood the purpose of the trial, the nature of the mindfulness intervention and the trial drugs, the possible risks of the trial and their own rights and interests. They voluntarily participated in the clinical trial and signed the informed consent form (ICF); 6. Be willing and able to complete scheduled study visits as required by the protocol.
Exclusion criteria
Exclusion criteria: 1.Participation in any other interventional clinical trial within the past 3 months. 2.Meeting the Chinese Dry Eye Expert Consensus criteria for severe dry eye in either eye at screening: Corneal damage involving >=2 quadrants on slit-lamp examination, and/or >=30 corneal fluorescein staining points with TBUT 5 cigarettes/day or alcohol consumption >14 units/week (1 unit=360mL beer/45mL 40% spirits/150mL wine) within past 3 months or anticipated during study. 12.IOP >21 mmHg in either eye, history of glaucoma/ocular hypertension, or current use of anti-glaucoma medications. 13.Study site staff or their immediate family members involved in trial administration. 14.History of drug dependence, substance abuse, or narcotic use within past 5 years. 15.Pregnant/lactating women, or women of childbearing potential planning pregnancy. 16.Diagnosis of moderate-to-severe anxiety/depression within past year or current related medication use. 17.Chronic use of sleep medications for sleep disorders. 18.Inability/unwillingness to complete ocular examinations/questionnaires, or cognitive impairments. 19.Investigator judgment of likely non-compliance with protocol or inability to administer eye drops properly. 20.Corneal fluorescein staining score >5 points (NEI scale) in either eye.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ocular Surface Disease Index (OSDI) score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Acuity;Intraocular Pressure;Non-Invasive Tear Film Break-Up Time (NIBUT);Fluorescein Tear Break-Up Time;Corneal Fluorescein Staining (CFS) Score;Tear Meniscus Height (TMH);Ocular Redness Index (ORI);Pittsburgh Sleep Quality Index (PSQI) Score;36-Item Short Form Health Survey (SF-36) Score;Perceived Stress Scale (PSS) Score;General Well-Being Schedule (GWB) Score;Five Facet Mindfulness Questionnaire (FFMQ) Score; | — |
Countries
China
Contacts
Public ContactDan Jiang
Eye Hospital, Wenzhou Medical University
Outcome results
None listed