Blepharitis
Conditions
Interventions
Experimental group:0.01% hypochlorous acid cleans the eyelid margin
Control group:Saline cleans the eyelid margin
Sponsors
Beijing Tongren Hospital, Capital Medical University
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) Clinical signs and symptoms of blepharitis: eyelid margin congestion, thickening, crusting and ulceration; Eyelash changes include eyelash loss, ingrowth, follicular epithelial hyperplasia, cuff sleeve scale at the base of the eyelashes; meibomian gland opening, lipid plug, obstruction, or keratinization, meibomian gland atrophy or recurrent chalazion formation; eyelid margin brush keratinization, epithelial staining, etc.; Clinical examination is consistent with the characteristics of a specific type of blepharitis: (1) Staphylococcal blepharitis: the eyelids are mostly accompanied by eyelash root ulcers, eyelid margin ulcers and external blepharitis; (2) Seborrheic blepharitis: mainly Demodex blepharitis, in line with the diagnosis of blepharitis, combined with positive Demodex test; (3) Meibomian gland dysfunction blepharitis: consistent with the diagnosis of blepharitis, the onset involves the meibomian gland, often accompanied by foamy lipid secretions; (4) Have not participated in other drug clinical trials within 2 weeks of the trial; (5) Not being treated with other medications for blepharitis, or being treated with other medications but having been 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 within 14 days prior to Visit 0: systemic, nasal, inhaled, ocular topical or topical antibacterial, antiparasitic, or anti-inflammatory steroid therapy; (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 Intense Pulsed Light (IRPL), within 14 days prior to Visit 0, or is unwilling to abstain from the use of these treatments for the duration of the study; (6) Initiation of ocular topical prostaglandin analogue therapy within 30 days prior to Visit 0, or planned change or discontinuation of treatment during the study; (7) use of prostaglandin analogues to promote eyelash growth within 30 days prior to Visit 0, or planned initiation of treatment during the study; (8) 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; (9) Abnormal eyelid anatomy, resulting in incomplete eyelid closure, including entropion and ectropion or eyelid laxity syndrome, thereby exposing a portion of the conjunctiva or impairing the blinking function of the eye; (10) Received or removed a permanent punctal plug within 3 months (6 months for soluble punctal plugs) prior to Visit 1, or is expected to undergo a punctal plug installation or removal related procedure during the trial, or presence of punctal plugs that may dissolve during the trial; (11) Have ocular or periocular malignant tumors; (12) Corneal epithelial defect, corneal staining obvious fusion or filamentous matter on the cornea; (13) History of herpetic keratitis; (14) Active ocular allergies or possible ocular allergies during the trial; (15) Has been diagnosed with an ongoing ocular or systemic infection (bacterial, viral, or fungal), including fever, or is receiving antibiotic therapy; (16) Previous intraocular surgery or intraocular laser surgery within the past 6 months, or planned to undergo any ocular and/or eyelid surgery within the duration of the trial; (17) Family members (living together) of the subjects in this trial; (18) Clinical site employees who are directly involved in the operation, management, or support of this trial, or their immediate family members; (19) Women who are pregnant, breastfeeding, or planning to become pregnant during the trial; (20) Patient has uncontrollable systemic disease in the opinion of the investigator; (21) Has a known allergy and/or sensitivity to the drug or saline component under study; (22) Has active ocular or periocular acne that, in the judgment of the investigator, may interfere with the trial (e.g., clinically relevant eyelid induration); (23) Pterygium in either eye; (24) Is currently participating in other drug or device trials, or has participated in other drug or device trials within
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OSDI questionnaire;Eyelid margin erythema classification;Eyelid margin signs;Tear Meniscus Height;Demodex infection; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bacterial load and classification of ocular surface;Meibomian gland assessment;Tear film break-up time;Schirmer test without anesthesia;Fluorescent corneal staining; | — |
Countries
China
Contacts
Public ContactYing Jie
Beijing Tongren Hospital, Capital Medical University
Outcome results
None listed