Dry Eye
Conditions
Interventions
Test group:Insertion of Absorbable Tacrolimus Lacrimal Canalicular Plug
Control group:Insertion of Dissolvable VisiPlug
Sponsors
Beijing Tongren Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old; 2. At the screening period and baseline visit, the patient must have dry eye as evidenced by both the following signs and symptoms, and the same eye (study eye) must meet all the following criteria: (1) tCFS score >= 6 points; (2) OSDI score >= 23 points; (3) Dry eye symptom score >= 40 points according to the VAS; (4) Schirmer? Test: >= 1 mm and = 6 months; 4. Currently using or having used lubricating gel or artificial tears for dry eye, but still experience dry eye symptoms; 5. Best Corrected Visual Acuity (BCVA) >= 0.2 in both eyes; 6. The subject or their legal guardian voluntarily signs the ICF, clearly understands the benefits and risks of the study, and has good compliance; 7. The subject must have the ability and willingness to comply with the study procedures.
Exclusion criteria
Exclusion criteria: 1. Abnormal punctal structure of both eyes, making it impossible to place lacrimal canalicular plugs in the lower punctum of the study eye; or subjects for whom the investigator assesses that the desired effect may not be achieved due to ocular structure after placement; 2. A history of malignant tumors in the eye/periorbital region or other parts of the body; unstable systemic diseases within 1 month prior to screening; or conditions judged by the investigator to be incompatible with the study or unable to meet the requirements of study visit follow-up; 3. Subjects with other autoimmune diseases; 4. Subjects with secondary ocular scars that the investigator assesses may affect subject compliance or outcome evaluation; 5. Subjects with a history of possible or confirmed ocular infection or ocular herpes in either eye; 6. Subjects with concurrent severe diseases of the heart, liver, kidneys, cerebrovascular system, and hematopoietic system; 7. Structural abnormalities, blink abnormalities, or ocular diseases in either eye that may affect trial evaluation within 1 month prior to screening; 8. Subjects requiring treatment with any topical or systemic antibiotics, topical steroids, or other prescription drugs, or with diseases that may require such drug treatment during the trial; 9. Use of the following ocular medications within the specified period prior to screening: 1) Topical or systemic antihistamines: within 14 days prior to screening for any ocular medication; 2) Topical immunosuppressants: within 6 weeks prior to screening; 3) Topical, inhaled, intranasal, or topical cutaneous corticosteroids, mast cell stabilizers: within 14 days prior to screening; 4) Other drugs for dry eye treatment: within 14 days prior to screening; 10. Receipt of other dry eye treatments within 30 days prior to screening; 11. Dry eye caused or exacerbated by ocular surgery that has not yet stabilized; 12. Diagnosis of chronic epiphora due to lacrimal canalicular obstruction or lacrimal duct inflammatory diseases within 6 months prior to screening; 13. Use of contact lenses or scleral lenses within 2 weeks prior to screening, or planned use during the study period; 14. Use of systemic or topical drugs known to cause dry eye or affect efficacy evaluation within 7 days prior to screening; 15. Use of any serum tears, oral doxycycline, oral tetracycline, or any ocular drugs/cosmetics that promote eyelash growth within 30 days prior to screening, and inability to discontinue use during the study. 16. Planned use of any topical ophthalmic drugs or prescriptions other than the specified study drugs during the study period; 17. Previous corneal transplantation or planned corneal transplantation during the study period; 18. A history of any ocular surface surgery or external eye surgery within 6 months prior to screening, or planned ocular or eyelid surgery during the study period; 19. A history of intraocular surgery, ocular laser surgery, Nd:YAG laser capsulotomy, or any other surgery affecting the meibomian glands within 6 months prior to screening; 20. Intraocular pressure (IOP) exceeding 21 mmHg in either eye; or a history of glaucoma or ocular hypertension; or receipt of antiglaucoma drug treatment in either eye; or receipt of antiglaucoma laser or surgical treatment in the study eye within 90 days prior to screening; 21. Receipt or removal of lacrimal canalicular plugs within 3 months prior to screening, or a history of surgery for severe dry eye; 22. Current p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Schirmer I test; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total Corneal Fluorescein Staining (tCFS) Score;Conjunctival Fluorescein Staining Score;Fluorescein Staining Tear Film Break-Up Time (FBUT);Ocular Surface Disease Index (OSDI);Eye Dryness Score; | — |
Countries
China
Contacts
Public ContactYing Jie
Beijing Tongren Hospital Affiliated to Capital Medical University
Outcome results
None listed