Dry eye syndrome
Conditions
Interventions
Phase III Control Group:Standardized artificial tear therapy (0.1% sodium hyaluronate eye drops, 4 times daily)
Phase I Trial Group:30-second single eye area massage
Phase II Trial Group:VDT Visual Tasks and Periorbital Massage
Phase III Trial Group:Perform eye contour massage therapy 4 times daily (for a total of 8 weeks)
Sponsors
Eye Hospital, Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.Aged between 18 and 45 years old (including both endpoints); 2.Meets the diagnostic criteria for TFOS Dry Eye Diagnostic Methodology; and exhibits the following two signs in the same eye: Ocular Surface Disease Index (OSDI) score: 13–80; Non-invasive tear breakup time (NIBUT) < 10 seconds; If both eyes meet the criteria, include the eye with more severe objective signs, selecting the eye with the shorter NIBUT. 3.Willing and able to conscientiously complete the study according to the protocol requirements, including all scheduled visits during the study period. 4.Subjects voluntarily participated in this clinical trial and signed an informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1.A score from the National Eye Institute’s corneal fluorescein staining examination of more than 5; 2.Use of any dry eye disease treatment or other medications in the 7 days before enrolment; 3.Individuals who have undergone physical therapies such as meibomian gland massage or laser pulse therapy, or other dry eye treatments within the past month. 4.Any lacrimal duct disease, severe meibomian gland disease, or blepharitis; 5.Any eye surgery or history of ocular trauma within the past 3 months; 6.Contact lens usage within 14 days before screening visit or who cannot avoid using them during the study period; 7.Severe ocular surface scarring or conditions that could compromise the integrity of the ocular surface: History of ocular allergy or infection within the past 3 months; Excessive eyelid laxity, eyelid laxity syndrome, ectropion, entropion, or moderate to severe pinguecula or pterygium as assessed by the investigator; Systemic immune disorders such as Stevens-Johnson syndrome, systemic lupus erythematosus, rheumatoid arthritis, or severe Sjögren's syndrome; Significant conjunctival or corneal scarring as assessed by the investigator; Severe/critical ocular disease that, in the investigator's judgment, may interfere with study assessment or limit compliance; f. Severe/critical systemic diseases or poorly controlled medical conditions that, in the investigator's judgment, may interfere with study assessments or limit compliance; 8.Participants enrolled in any other clinical trial at the same time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ocular surface disease index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Computer Vision Syndrome;Fluorescein tear film break-out time;Corneal Fluorescein Staining Score;Bulbar Redness;Symptom in Dry Eye;Function Visual Acuity;Tear meniscus height;Noninvasive breakup time;Assessment indicators under slit lamp ;Lipid layer thickness; | — |
Countries
China
Contacts
Public ContactWei Chen
Eye Hospital, Wenzhou Medical University
Outcome results
None listed