Staphylococcal blepharitis, seborrheic blepharitis (including Demodex blepharitis), and meibomian gland dysfunction-associated blepharitis
Conditions
Interventions
control group:Saline cleans the eyelid margin
Experimental group:EYESU+ eyelid cleaning wipes clean the eyelid margin
Sponsors
Bejing Tongren Hospital, Capital Medical Uniersity
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Voluntarily participate in this clinical study and sign the informed consent form; 2.Gender is not limited, age 18~70 years old; 3.Typical history and characteristic signs and signs of blepharitis: Typical medical history: (1) ocular surface irritation symptoms, eye redness, foreign body sensation, photophobia, lacrimation, recurrent blepharitis (stye); (2) The condition is more severe in the morning or morning; (3) Have systemic diseases, such as rosacea, history of local radiotherapy and chemotherapy, etc. Characteristic signs: (1) facial rosacea; (2) Eyelid abnormalities, including abnormal position, eyelid margin hyperemia, sparse or messy eyelashes, eyelid margin ulcers, etc.; (3) Foamy discharge from the eyelid margin, conjunctival injection, vesicular keratoconjunctivitis, filamentous keratitis, corneal epithelium punctate detachment, corneal ulcer, etc. In addition, blepharitis is classified according to the following identification points: (1) Staphylococcal blepharitis is often accompanied by eyelash loss, eyelash root ulcer, eyelid margin ulcer, corneal epithelial punctate detachment and even ulcer at the corresponding part of the eyelid margin; (2) Patients with seborrheic blepharitis are often accompanied by seborrheic dermatitis, which rarely involves eyelashes, and corneal epithelium can be punctately shedding; (3) Meibomian gland dysfunction blepharitis can be accompanied by rosacea, mainly involving meibomian glands, such as the appearance of meibomian version number: 2025TRAS-0001 Version date: 2025.01.09 9 Adenitis (stye), foamy lipid discharge, meibomian gland atrophy, etc. Have not participated in other drug clinical trials within 2 weeks of the trial. 4.Not being treated with other medications for blepharitis, or being treated with other medications but off for more than 2 weeks.
Exclusion criteria
Exclusion criteria: 1.Significant abnormalities in slit-lamp microscopy at Visit 0 and Visit 1 and/or judgment by the investigator that may affect the evaluation of test indicators, including ocular trauma and history of ocular trauma; 2.Received prescription medications: systemic, nasal, inhaled, ocular topical or topical antibacterial, antiparasitic, or anti-inflammatory steroid therapy within 14 days prior to Visit 0; 3.Topical tea tree oil, okra eye patch, or hypochlorous acid treatment of the eye within 14 days prior to Visit 0 or unwilling to abstain from these treatments for the duration of the study; 4.Use of eyelid cleaning products (e.g., eyelid cleaning solution) within 14 days prior to Visit 0 or unwilling to abstain from the use of eyelid cleaning products for the duration of the study; 5.Received intense pulsed light (IPL) therapy, such as Optimized Pulsed Technique (OPT) or Accentuated Joint Pulsed Light (IRPL), within 14 days prior to Visit 0, or is unwilling to abstain from these treatments for the duration of the study; 6.Use of prostaglandin analogues to promote eyelash growth within 30 days prior to Visit 0, or planned initiation of treatment during the study; 7.Use of artificial eyelashes, eyelash extensions, or other cosmetic eyelash or eyelid surgeries (e.g., eyeliner tattoos, eyelash tinting, eyelash curls, etc.) within 7 days prior to Visit 0, or unwilling to abstain from use during the study; 8.Eyelid anatomy is abnormal, resulting in incomplete eyelid closure, including entropion and ectropion or laxity syndrome, exposing a portion of the conjunctiva or impairing the eye's blinking function; 9.Received or removed a permanent punctal plug within 3 months (6 months for soluble punctal plugs) prior to Visit 1, or is expected to perform procedures related to punctal plug installation or removal during the trial, or presence of punctal plugs that may dissolve during the trial; 10.Have ocular or periocular malignancy; 11.There is a corneal epithelial defect, corneal staining is markedly confluent, or filaments are seen on the cornea; 12.Has a history of herpetic keratitis; 13.Active ocular allergies or may develop ocular allergies during the trial; 14.Have been diagnosed with an ongoing ocular or systemic infection (bacterial, viral, or fungal), including fever or on antibiotic therapy; 15.Previous intraocular surgery or intraocular laser surgery within the past 6 months, or planned to have any ocular and/or eyelid surgery within the duration of the trial; 16.Family members (living together) of participants in this trial; 17.Clinical site employees who are directly involved in the operation, management, or support of this trial, or their immediate family members; 18.Women who are pregnant, breastfeeding, or planning to become pregnant during the trial; 19.In the opinion of the investigator, the patient has uncontrollable systemic disease; 20.Has a known allergy and/or sensitivity to the drug or saline component being studied; 21.Has active ocular or periocular acne that, in the judgment of the investigator, may interfere with the trial (e.g., clinically relevant eyelid induration); 22.Currently participating in other drug or device trials, or have participated in other drug or device trials within 60 days prior to Visit 1; 23.Use of any oral medication (such as antihistamines, antidepressants, etc.) known to cause ocular dryness within 1 month prior to Visit 0, or anticipation of irregular use of oral medication that causes ocular dryn
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS questionnaire score;tarpabral margin erythema grade;palpebral margin sign score;Eyelid margin microbial assay; | — |
Countries
China
Contacts
Public ContactTian lei
Bejing Tongren Hospital, Capital Medical Uniersity
Outcome results
None listed