New gel treatment could soothe diabetic eyes

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 1\. Patients with fasting blood glucose ≥ 7.0 mmol/L or 2-hour postprandial blood glucose ≥ 11.1 mmol/L. 2\. Those who clearly understand and voluntarily participate in this study, and sign the written informed consent form themselves, and are able and willing to follow the instructions to participate in all trial evaluations and visits. 3\. Male subjects and female subjects of childbearing age must agree to use medically approved contraceptive measures during the trial and for 90 days after the trial. For female subjects who have not reached menopause or have been menopausal for less than two years, the pregnancy test must be negative. 4\. A history of severe dry eye symptoms (including one or more of the following subjective symptoms: dryness, foreign body sensation, burning sensation, fatigue, discomfort, redness, sudden eye pain, photophobia, tearing, blurred vision, and decreased corneal sensation) in both eyes for at least 180 days before the screening visit (Visit 0). 5\. Currently (within 30 days before Visit 0) using artificial tears to relieve dry eye-related symptoms, and artificial tears must be discontinued 72 hours before Visit 0. 6\. At Visit 0, the Chinese Dry Eye Questionnaire score is \> 7 points or the total score of the Ocular Surface Disease Index is \> 13 points. 7\. At Visit 0 and Visit 1, the dryness score is \> 40 points. 8. At Visit 0, the best corrected visual acuity of both eyes is ≥ 4.3 (5-meter reading on the international standard logarithmic visual acuity chart, 5-point recording method). 9\. At Visit 0 and Visit 1, the corneal fluorescein staining score of at least one area of at least one eye is ≥ 2 points. 10\. At Visit 0 and Visit 1, the conjunctival redness score of at least one eye is ≥ 1 point. 11\. At the screening visit and baseline visit (Visit 0 and Visit 1), at least one eye of the same subject meets the following criteria: a. The corneal lower zone fluorescein staining score is ≥ 0.5 points; b. The Schirmer's test without anesthesia is ≥ 1 and ≤ 10 mm/5 min. Exclusion Criteria: 1. Any past or current malignancy in or around the eye. 2. Dry eye traced to scarring (radiation, alkali burn, Stevens-Johnson, cicatricial pemphigoid) or goblet-cell loss (vitamin-A deficiency). 3. Active ocular allergy now or expected during the study. 4. Ocular or systemic infection at screening/baseline-fever, herpetic keratitis, or on antibiotics. 5. Prior immunodeficiency, HIV, hep B/C, active hep A, organ or bone-marrow transplant. 6. Any serious chronic illness the PI thinks could mess with endpoints-severe heart/lung disease, uncontrolled hypertension or diabetes. 7. Blood donation or major blood loss within 8 weeks of screening. 8. Active ocular rosacea, periorbital acne, or pterygium. 9. Lid problems-lagophthalmos, entropion, ectropion, or abnormal blink. 10. Clinically relevant slit-lamp findings needing treatment (conjunctivitis, trichiasis, conjunctivochalasis) that could skew results. 11. Eye surgery or laser (including YAG, meibomian thermopulsation, IPL) within 6 months of screening, or any such plan during the trial. 12. Punctal plugs (non-dissolvable within 90 days; dissolvable within 180 days) or planned plug procedures during the study. 13. Systemic steroids, immunomodulators, oral doxy/tetracycline within 90 days, or on-and-off use planned. 14. Topical glaucoma meds within 90 days. 15. Cyclosporine-A or lifitegrast drops within 42 days. 16. Drugs well known to dry the eye-diuretics, antidepressants, decongestants, antispasmodics, antihistamines, etc.-within 30 days or irregular use expected. 17. Active blepharitis/MGD therapy (lid scrubs, meibomian massage, warm compresses, systemic antibiotics) within 30 days or sporadic use planned. 18. Topical steroid or mast-cell stabilizer on the eye/face within 2 weeks. 19. Contact-lens wear within 7 days or intent to keep wearing them during the study.