Dry Eye Disease
Conditions
Interventions
Experimental Group:Treatment with YS245 Eye Drops
Sponsors
The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Those who voluntarily participate and sign the informed consent form are willing to follow the treatment schedule stipulated in the trial protocol and to undergo regular follow-ups. 2) Age >= 18 years old, gender not restricted. 3) At the screening visit (V1 visit), the best corrected visual acuity of both eyes (OU) is >= 4.3. 4) Before the screening visit (V1 visit), there is a history of dry eye disease in both eyes (at least one of the subjective symptoms such as eye dryness, foreign body sensation, burning sensation, fatigue, discomfort, redness, and vision fluctuation exists). 5) The tear film break-up time at the screening visit (V1 visit) meets one of the following criteria: i. The corneal damage area exceeds 2 quadrants, and/or the number of corneal fluorescein staining points is >= 5; ii. TBUT = 23 points. 8) At the V1 visit, the conjunctival congestion score of both eyes is >= 1 and remains at the baseline level. 9) At the V1 visit, the EDS score is >= 40 (OU) and remains at the baseline level.
Exclusion criteria
Exclusion criteria: 1) Those currently suffering from herpes keratitis or any other ocular infection or inflammation, or having a history of herpes keratitis or any other ocular infection within 30 days prior to the screening. 2) Those with abnormal eyelid structure (such as ectropion, entropion, eyelid laxity, etc.), severe conjunctival laxity, Salzmann nodular keratopathy, damaged conjunctival goblet cells (such as vitamin A deficiency), progressive pterygium, wet age-related macular degeneration (wAMD), glaucoma, diabetic retinopathy, retinal vein occlusion, etc., and the researcher believes that this disease may increase the risk for the subjects or may affect the trial results. 3) Those with secondary secondary Sjogren's syndrome or other autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus, etc.) and the researcher assesses that it may affect the subject's compliance or result assessment. 4) Those with secondary Sjogren's syndrome or other autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus, etc.). Unless the subject meets the following conditions: a. Not using corticosteroid drugs, immunomodulatory or immunosuppressive drugs to treat the disease; b. The researcher believes that their medical condition will not affect the trial results. 5) Those who have undergone organ or bone marrow transplantation. 6) Those who have worn contact lenses within 30 days prior to the screening. 7) Those who have received physical therapy for dry eye (including eyelid scrubbing, meibomian gland massage, hot compress, etc.) within 30 days prior to the screening. 8) Those who have taken aspirin or aspirin-containing drugs orally within 30 days before administration, or used non-steroidal drugs (including eye or systemic use) and drugs that cause eye dryness (such as anticholinergic drugs, 5-hydroxytryptamine reuptake inhibitors, etc.). Unless the subject has been using the drug stably for at least 30 days before the baseline visit and the expected dosage during the trial does not change. 9) Those who used the following drugs within the specified time before administration: a. Eye or systemic use of antihistamines, any eye medication: within 14 days before administration; b. Eye cyclosporine, tacrolimus: within 6 weeks before administration; c. Eye or systemic use of steroids, mast cell stabilizers: within 14 days before administration. 10) Those who have implanted a punctum plug/tear duct plug or have a history of punctum burning within 12 weeks prior to the screening. 11) Those who have used anti-glaucoma drugs within 3 months prior to the screening, or have undergone non-laser glaucoma surgery, or have undergone glaucoma laser surgery within 6 months prior to the screening visit. 12) Those who have undergone yttrium aluminum garnet laser posterior capsule incision within 6 months prior to the screening; those who have undergone corneal refractive surgery (such as LASIK surgery) within 12 months prior to the screening. 13) Those known to be allergic to fluorescein, allergic to multiple substances or have severe allergic diseases. 14) Those with other difficult-to-control clinical problems (such as severe chronic infection, severe heart or lung diseases, poorly controlled hypertension [defined as a systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 100 mmHg after antihypertensive drug treatment], poorly controlled diabetes, and malignant tumors, etc.). 15) Those with a positive pregnancy test or lacta
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lower corneal fluorescein staining; | — |
Secondary
| Measure | Time frame |
|---|---|
| OSDI Score;Schirmer Tear Test (STT);Tear Break-Up Time (BUT);Ocular Discomfort Score;Eye Dryness Score (EDS, 0-100).;Adverse event record;Conjunctival staining score (Lissamine green;Total Corneal Fluorescein Staining Score (TCSS);Conjunctival Hyperemia Score; | — |
Countries
China
Contacts
Public ContactLi Shiying;Shen Dongyan
The First Affiliated Hospital of Xiamen University
Outcome results
None listed