dry eye
Conditions
Interventions
experimental group:Jinzhen Eye Drops, instill 1-2 drops in each eye, four times a day.
control group:lacebo, instill 1-2 drops in each eye, four times a day (QID)
Sponsors
Beijing Tongren Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1.Age = 18 years old. 2.Signed written informed consent. 3.Patients with a complaint of dry eye symptoms for at least 6 months at the screening visit (Visit 0). 4.Ocular Surface Disease Index (OSDI©) score = 13 at Visit 0 and Visit 1. 5.Fluorescein Break-Up Time (FBUT) = 10 seconds or Schirmer I test (without anesthesia) = 10 mm/5 min at Visit 0 and Visit 1. 6.Positive fluorescein sodium staining of the cornea (= 5 dots) and a total score on the corneal fluorescein staining (NEI scale) of 2 = X = 8 (sum of scores in the inferior, superior, central, nasal, and temporal regions) at Visit 0 and Visit 1. 7.At least one eye (the same eye) meeting all the criteria of 3, 4, 5, and 6 at Visit 0 and Visit 1. 8.Able and willing to comply with all study assessments and visits as instructed.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from participating in this study: 1. Clear abnormalities observed during the slit-lamp examination at Visit 0 and Visit 1, and/or assessed by the investigator to potentially affect the evaluation of study endpoints, including ocular trauma or a history of ocular trauma. 2. History of Steven Johnson syndrome. 3. Active meibomian gland inflammation or anterior blepharitis within 30 days prior to Visit 0, requiring local or systemic antibiotic or topical corticosteroid treatment, or requiring such treatment during the trial. Other treatments such as eyelid scrubbing or warm compresses must not have been stable within the 30 days prior to Visit 0 and throughout the entire trial. 4. LipiFlow treatment, meibomian gland expression, or any other treatment affecting the meibomian glands within 1 month prior to Visit 1. 5. Abnormal eyelid anatomy resulting in incomplete eyelid closure, including entropion, ectropion, or floppy eyelid syndrome, exposing a portion of the conjunctiva or impairing the blinking function of the eye. 6. Received or had planned installation or removal of permanent punctal plugs within 3 months prior to Visit 1 (soluble punctal plugs for 6 months), or anticipated dissolution of punctal plugs during the trial. 7. Secondary dry eye resulting from scars, radiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells (such as vitamin A deficiency). 8. Malignant tumors of the eye or periocular region. 9. Corneal epithelial defects, significant corneal staining, or filamentary keratitis observed on the cornea. 10. History of herpetic keratitis. 11. Active ocular allergies or the potential for ocular allergies to occur during the trial. 12. Diagnosed with active ocular or systemic infection (bacterial, viral, or fungal), including fever or undergoing antibiotic treatment. 13. Wore contact lenses within 2 weeks prior to Visit 0 or planned to wear contact lenses during the trial. 14. Used any eye drops and/or the TrueTearTM device (nasal neurostimulator for tear production) within the past 24 hours prior to Visit 1. 15. Underwent intraocular or laser eye surgery within the past 6 months or had plans for any eye and/or eyelid surgery during the trial. 16. Family members (cohabiting) of study participants. 17. Clinical research center staff directly involved in the conduct, management, or support of the study, or their immediate family members. 18. Pregnant, breastfeeding, or planning to become pregnant during the trial. 19. Women of childbearing potential unwilling to undergo pregnancy testing at Visit 0, Visit 1, and Visit 4 (or early termination). 20. Women of childbearing potential not using an acceptable method of contraception (acceptable methods include hormonal-oral, implant, injectable, or transdermal contraception; mechanical-spermicidal with barrier methods such as diaphragm or condom; intrauterine contraceptive device (IUD); or surgical sterilization of the partner). 21. Patients with systemic diseases deemed uncontrollable by the investigator. 22. Known allergy and/or sensitivity to the investigational drug or saline components. 23. Active ocular or periocular acne that the investigator deems likely to interfere with the trial (e.g., clinically significant chalazia). 24. Presence of a pinguecula in either eye. 25. Currently participating in another drug or device trial or participated in another drug or device trial within 30
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Corneal fluorescein staining score;visual analogue scale;Assessment of meibomian gland function; | — |
Secondary
| Measure | Time frame |
|---|---|
| breakup time of tear film;Schirmer test; | — |
Countries
China
Contacts
Public ContactJie Ying
Beijing Tongren Hospital
Outcome results
None listed