Dry eye disease
Conditions
Interventions
Experimental Group 1:Study subjects apply the medication to the skin (concentration 10mg/g, 1%) four times a day, with approximately 5mg applied each time.
Experimental Group 2:Study subjects apply the medication to the skin (concentration 20mg/g, 2%) four times a day, with approximately 5mg applied each time.
Experimental Group 3:Study subjects apply the medication to the skin (concentration 40mg/g, 4%) four times a day, with approximately 5mg applied each time.
Control group:Placebo solvent applied to the skin (concentration 0mg/g, 0%) four times a day, with approximately 5mg applied each time.
Sponsors
Beijing Tongren Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (2) Gender is not limited, age between 18 to 70 years old. (3) At the screening visit, the Eye Dryness Score (EDS) >=40. (4) At the screening visit, the study eye satisfies all of the following: • At least one corneal area has a CFS score >=2, or the total score for all corneal areas is =4. • Baseline Schirmer test (with local anesthesia) score =0.2). (11) Provides verbal and written informed consent, is able and willing to use the experimental drug, and participate in all study assessments and visits. (12) If the female is of childbearing potential, she must use acceptable contraception methods (acceptable methods include: hormonal - oral, implantable, injectable or transdermal contraceptives; mechanical - spermicides combined with barrier methods such as a diaphragm or condom; intrauterine device; or partner sterilization), and at screening, the pregnancy test result must be negative. (13) Has literacy skills and is able to independently complete the questionnaire.
Exclusion criteria
Exclusion criteria: (1) Presence of clinically significant corneal epithelial defects (e.g., neurotrophic keratitis) at the screening visit prior to performing the Schirmer test. (2) History of facial surgery (including facial trigeminal nerve resection) or significant trauma to the periocular areas affecting trigeminal nerve function. (3) Examination prior to the screening visit confirms the presence of facial dermatological conditions such as dermatitis (including seasonal dermatitis, seborrheic dermatitis, steroid-dependent dermatitis, contact dermatitis, etc.), rosacea, or other facial skin diseases. (4) Any eye has undergone intraocular surgery (e.g., cataract surgery) within 3 months prior to the screening visit, or any eye has undergone refractive surgery (e.g., LASIK, LASEK, PRK, or corneal implant) within 12 months. (5) Any eye has undergone blepharoplasty. (6) Any eye has undergone a corneal transplant. (7) Topical ocular medications containing cyclosporine (e.g., cyclosporine eye drops) or tacrolimus (e.g., tacrolimus eye drops) have been used within 60 days prior to the screening visit. (8) Topical ocular medications containing serum (e.g., autologous serum and bovine serum albumin extracts), corticosteroids (e.g., tobramycin-dexamethasone eye drops), or growth factors (e.g., Befusuo [recombinant bovine basic fibroblast growth factor eye drops]) have been used within 30 days prior to the screening visit. (9) Diquafosol (e.g., diquafosol sodium eye drops) has been used within 14 days prior to the screening visit. (10) Contact lenses have been worn within 7 days prior to the screening visit, or are expected to be used during the study treatment period. (11) Presence of any form of punctal or canalicular occlusion. (12) Any eye, past or present, with an eye disease or condition that the investigator believes may interfere with the interpretation of study results or jeopardize the subject's safety, such as severe corneal or conjunctival scarring; pterygium or nodular conjunctival limbal lesions; current ocular infection, acute conjunctivitis, or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophies or degenerations; ocular herpes infection; evidence of keratoconus, etc. Mild blepharitis and typical meibomian gland disease associated with DED, which require no treatment, are acceptable. (13) History of seizures or other factors that lower the subject's seizure threshold. (14) Presence of unstable or systemic conditions or diseases that the investigator determines to be unsuitable for participation in the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disorder, myocardial infarction or heart disease history, etc.). (15) Known allergy to any of the drugs and formulations used or expected to be used in the trial, or to any component of the investigational drug. (16) Use of acetylcholine receptor (nAChR) agonists (e.g., nicotine, lobeline, varenicline, etc.) within 30 days prior to the screening visit, or expected use of these drugs during the treatment period. (17) Currently using any neurostimulation devices, such as TrueTear, iTear, etc. (18) Presence of active or uncontrolled severe systemic allergies, chronic seasonal allergies, or facial diseases that require treatment during the study treatment period, or are expected to require treatment during the study treatment period. (19) Any condition or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EDS Questionnaire;Schirmer test;OSDI Questionnaire; | — |
Secondary
| Measure | Time frame |
|---|---|
| tear break up time, BUT;MGD score;VAS Questionnaire;Corneal Fluorescein Staining Score;Subjective experience;tear meniscus height,TMH; | — |
Countries
China
Contacts
Public ContactYing Jie
Beijing Tongren Hospital, Capital Medical University
Outcome results
None listed