Dry Eye
Conditions
Interventions
HBM9036(HL036) Eye Drops:Local administration of HBM9036 (HL036) eye drops (0.25%) to eyes, once in the morning and once in the evening, and the treatment lasts for 8 weeks
Placebo Eye Drops:Local administration of placebo to eyes, once in the morning and once in the evening, and the treatment lasts for 8 weeks
Sponsors
Xiamen Eye Center Affiliated to Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. At least 6 months history of any dry eye symptoms; 2. Must use or feel the need to use any types of eye drops to treat dry eye disease symptoms within 6 months prior to Screening Visit; 3. Best corrected visual acuity (BCVA) >= logMAR+0.7 as assessed according to the Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at Screening Visit; 4. At least 1 eye dryness score >= 40mm measured by 100mm Visual Analogue Scale (VAS) at Screening Visit; 5. Schirmers test score (anesthetized) >= 1mm and = 5.5 according to the Ora Calibra Corneal and Conjunctival Staining Scale at least in the study eye at Screening and Baseline Visits; 8. Conjunctival redness score >= 1 according to the Ora Calibra Conjunctival Redness Scale at least in the study eye at Screening Visit.
Exclusion criteria
Exclusion criteria: 1. At Screening Visit, Subjects observed by investigator with any clinically significant signs including active blepharitis and ocular allergies. Patients with meibomian gland dysfunction that need treatment; 2. Currently active ocular infection (bacterial, viral, or fungal) or any ocular surface inflammation; 3. Patients whose dry eye disease secondary to Sjogrens syndrome, Steven-Johnson Syndrome or chronic graft versus host disease, or patients suffered from serious autoimmune disorders such as systemic lupus erythematosus or rheumatoid arthritis, If their systemic disease are instable or drug application changed such as the type or dose of immunosuppressive biologics had been adjusted within 3 months or had drug withdrawal within 1 month or expected to have their drugs adjusted or discontinued during the study; 4. Planning to undergo any ocular or eyelid surgery; 5. Patients suffered from insertion of temporary lacrimal plug surgery within 6 months or insertion of permanent lacrimal plug surgery within 3 months. Or planning to undergo insertion of lacrimal plug surgery during the study; 6. Use of Cyclosporine A, Tacrolimus or Xiidra within 60 days prior to Screening Visit; 7. History of HBM9036 (HL036) use; 8. Currently use of prescription (including but not limited to antiglaucoma drops) or OTC drugs that locally applied to eyes, artificial tears, ophthalmic gel and eye rinse that cannot be interrupted during the study (excluding medications allowed in this study); pharmacological wash-out periods are required for some drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total corneal staining score (TCSS; superior, central, and inferior regions) of study eye evaluated by Ora Calibra Corneal and Conjunctival Staining Scale for Grading of Fluorescein Staining, change from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in corneal staining scores in the central area of the study eye as assessed by the Ora Calibra corneal and conjunctival fluorescein staining rating scale ;Change from baseline in the symptom score assessed by the Visual Analog Scale (VAS);Change from baseline in the study of eye conjunctival redness score assessed by Ora Calibra dry eye conjunctival redness scale ;Change from baseline in the total score of Ocular Surface Disease Index OSDI assessment ;Incidence and severity of ocular adverse events (AE);Incidence and severity of non-ocular AEs;The corrected visual acuity at all visits;Slit lamp biomicroscopy results at all visits;The tolerability of ophthalmic solution by ophthalmic tolerability scale and ophthalmic solution questionnaire;The intraocular pressure;The fundus photochromy;Serum immunogenicity test (for part of subjects); | — |
Countries
China
Contacts
Public ContactZuguo Liu
Xiamen Eye Center Affiliated to Xiamen University
Outcome results
None listed