Dry eye disease
Conditions
Interventions
10 µg/mL(0.001%) CF04 Ophthalmic Solution:Topical, ophthalmic solution for conjunctival sac of both eyes
60 µg/mL(0.006%) CF04 Ophthalmic Solution:Topical, ophthalmic solution for conjunctival sac of both eyes
Placebo(CF04 Vehicle Ophthalmic Solution):Topical, ophthalmic solution for conjunctival sac of both eyes
Sponsors
The Second Affiliated Hospital Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. When signing the ICF, =18 years old & = 75 years old (including the threshold), regardless of gender; 2. Have a history of diagnosed or clinically supported bilateral dry eye disease (diagnostic criteria can be found in Appendix 1); 3. During the screening period (Visit 1) and baseline period (Visit 2), the best corrected visual acuity (BCVA) of both eyes should be = 4.4 (standard logarithmic visual acuity chart); 4. During the screening period (Visit 1) and baseline period (Visit 2), at least one eye (the same eye) needs to meet all of the following criteria (each rating scale can be found in the Appendix): ? The inferior corneal fluorescein staining score (iFCS) score = 2 [Modified National Eye Institute (NEI) standard] and tFCS score = 4 ? The eye dryness scale score (EDS) in the Visual Analog Scale (VAS) score = 40 points or the total score of the Ocular Surface Disease Index (OSDI) score = 23 points ? FBUT = 5 sec ? 1 mm/5 min = Tear secretion Schirmer ? test = 10 mm/5 min 5. The subject and their spouse are willing to have no pregnancy plan and sperm donation plan within 3 months after the last administration, and voluntarily take effective contraceptive measures (see Appendix 9); 6. The subject is able to effectively use the electronic patient-reported outcome (ePRO) tool; 7. Voluntary to participate in the clinical trial, sign the ICF, and is willing to follow and complete all trial processes.
Exclusion criteria
Exclusion criteria: 1. Those with contraindications or allergies to investigational drugs (including excipients such as poloxamer) or diagnostic reagents (such as fluorescein sodium), or those evaluated as allergic constitutions by the investigator (such as having clinically significant allergies to more than 2 kinds of drugs or foods); 2. During the screening period (visit 1) or baseline period (visit 2), if there is an active infection, ocular inflammation or allergy in either eye, including but not limited to active blepharitis, active ocular allergy, and meibomian gland dysfunction requiring treatment; 3. Those with a history of ocular herpes, or those currently receiving long-term oral antiviral drug treatment for herpetic diseases; 4. Congenital complete absence of the lacrimal gland or meibomian gland in the study eye; 5. Significantly conjunctival scar formation in the study eye, as judged by the investigator; 6. Excessive eyelid relaxation, eyelid relaxation syndrome, ectropion, entropion or moderate to severe pterygium or pinguecula in the study eye; 7. A history of poorly controlled glaucoma and/or current glaucoma in either eye, intraocular pressure (IOP) exceeding 21 mmHg during the screening period (Visit 1) or baseline period (Visit 2), or currently receiving glaucoma treatment in either eye, or having received glaucoma laser or surgery within 90 days before screening (Visit 1); 8. Diagnosed with dry syndrome, Steven-Johnson syndrome or immune disease-related dry eye secondary to chronic graft-versus-host and other diseases; 9. Severe/serious ocular diseases, severe/serious systemic diseases or uncontrolled medical conditions that may confuse study evaluation or limit compliance, as judged by the investigator; 10. Used within the specified period before baseline (Visit 2): ? Systemic and ocular local immunosuppressants and immunotherapy (such as cyclosporine, tacrolimus, etc.): 30 days (ocular local administration), 60 days (systemic administration) ? Corticosteroids: 30 days ? Lifitegrast ophthalmic solution: 14 days ? Intranasal lacrimal nerve stimulation: 14 days ? Serum tears: 14 days ? Eye or oral non-steroidal anti-inflammatory drugs (NSAID): 7 days ? Eye or oral antihistamines or mast cell stabilizers: 7 days ? Eye or intranasal vasoconstrictors: 7 days ? Other local ophthalmic preparations (including artificial tears): 3 days 11. Change the administration regimen of the following drugs within 30 days before screening (Visit 1) or expected during the study period: ? Anticholinergic drugs ? Antidepressants ? Oral contraceptives 12. Those who need to wear contact lenses within 7 days before screening or during the study period; 13. Those who have undergone meibomian gland massage or humid chamber spectacle treatment within 7 days before screening, or have undergone non-drug methods for treating dry eye such as intense pulsed light therapy or thermal pulsation therapy within 6 months before screening; 14. Those who have undergone dry eye surgery, such as lacrimal duct embolization (current lacrimal duct embolization status or the use of punctal plugs within the past 6 months) or amniotic membrane transplantation, etc.; 15. Subjects who have received corneal transplantation or similar corneal surgeries in either eye; 16. Those who have undergone eyelid surgery within the past 6 months, or have any ocular surgery history expected within 3 months before screening; 17. Those who have undergone incision ocular surface surgery including but no
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in tFCS between the treatment group and the vehicle group after 42 days of treatment compared to baseline;Safety indicators include adverse events (AE), BCVA, IOP, slit-lamp microscope examination (both eyes' eyelids, eyelashes, cornea, conjunctiva, iris, anterior chamber and lens), wide-angle fundus photography (vitreous, retina, macula, choroid and optic nerve), corneal endothelial cell count examination, assessment of eyedrop comfort, blood routine, blood biochemistry and pregnancy test (women of childbearing age); | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences in OSDI scores between the treatment group and the vehicle group after 7, 14, 28, and 42 days of treatment compared to baseline;Differences in VAS scores between the treatment group and the vehicle group after 7, 14, 28, and 42 days of treatment compared to baseline;Differences in dry eye symptom assessment scale (SANDE) scores between the treatment group and the vehicle group after 7, 14, 28, and 42 days of treatment compared to baseline;Differences in tFCS between the treatment group and the vehicle group after 7 days, 14 days and 28 days of treatment compared to baseline and the differences in scores between the treatment group and the vehicle group after 7 days, 14 days, 28 days, and 42 days of treatment compared to baseline;Differences between the total score of conjunctival staining and the scores of each partition between the treatmnt group and the vehicle group after 7, 14, 28, and 42 days of treatment compared to baseline;Differences in conjunctival redness scores between the treatment group and the vehicle group after 7, 14, 28, and 42 days of treatment compared to baseline;The percentage difference in subjects with complete response of corneal fluorescence staining between the treatment group and the vehicle group after 7, 14, 28, and 42 days of treatment;The percentage difference in subjects with complete response of conjunctival staining between the treatment group and the vehicle group after 7, 14, 28, and 42 days of treatment;Differences in the Schirmer's I test between the treatment group and the vehicle group after 7, 14, 28, and 42 days of treatment compared to baseline;The percentage difference in subjects with Schirmer's I increase = 10 mm between the treatment group and the vehicle group after 7, 14, 28, and 42 days of treatment;Differences in FBUT between the treatment group and the vehicle group after 7, 14, 28, and 42 days of treatment compared to baseline;Test the anti-CF04 antibody in the serum. If the ADA test result is positiv | — |
Countries
China
Contacts
Public ContactXiuMing Jin
The Second Affiliated Hospital Zhejiang University School of Medicine
Outcome results
None listed