None listed
Conditions
Interventions
Medical Device : A total of 94 patients with dry eye disease will be randomly assigned in a 1:1 ratio to either the Biodegradable Microneedle Acupuncture (BMA) treatment group or the sham BMA control
Sponsors
Naju Dongshin University Korean Medicine Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female participants aged 19 to 70 years at the time of screening. 2) Participants with an Ocular Surface Disease Index (OSDI) score of 23 or higher at screening. 3) Participants with a tear film break-up time (TBUT) of 10 seconds or less in each eye at screening. 4) Participants who voluntarily provide written informed consent after receiving a full explanation of the clinical study. 5) Participants who are able and willing to comply with the study visit schedule and treatment procedures throughout the study period.
Exclusion criteria
Exclusion criteria: 1) Participants with dry eye disease caused by eyelid or eyelash abnormalities. 2) Participants with ocular irritation symptoms due to acute inflammation or infection of the eyelids, eyes, or ocular adnexa. 3) Participants who have worn contact lenses within 2 weeks prior to screening or who are expected to require contact lens use during the study period. 4) Participants who have undergone anterior segment surgery, such as cataract surgery or LASIK, within 3 months prior to screening. 5) Participants who have used anti-inflammatory ophthalmic medications, including cyclosporine, corticosteroids, or autologous serum eye drops, within 2 weeks prior to screening. 6) Participants diagnosed with vitamin A deficiency. 7) Participants with impaired blinking due to facial nerve palsy. 8) Participants who have undergone punctal plug insertion or punctal occlusion. 9) Participants with ocular or ocular adnexal injury resulting from trauma. 10) Participants with secondary dry eye disease caused by scar formation (e.g., radiation exposure, alkali burns, Stevens–Johnson syndrome, cicatricial pemphigoid, etc.). 11) Participants who have been diagnosed with or are suspected of having Sjögren's syndrome. 12) Participants currently receiving treatment for allergic eye disease or viral conjunctivitis. 13) Participants with an intraocular pressure (IOP) of =25 mmHg in one or both eyes, or those diagnosed with glaucoma. 14) Participants currently receiving systemic corticosteroid therapy or immunosuppressive treatment. 15) Participants with a known adhesive allergy. 16) Pregnant or breastfeeding women, or those planning to become pregnant during the study period. 17) Participants whom the investigator considers unsuitable for participation in the study for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tear film break-up time;Ocular surface disease index | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjective symptoms visual analog scale;Quality of life;Symptom Assessment in Dry Eye;Schirmer I test | — |
Countries
Korea, Republic of
Contacts
Public ContactSoo-Yeon Park
Dongshin University
Outcome results
None listed