Clinical trial: A Study Evaluating HBM9036 Efficacy and Safety on Moderate to Severe Dry Eye (NCT04633213)

Eligibility criteria:
Inclusion Criteria:

          1. Having a patient-reported history of dry eye for at least 6 months prior to
             enrollment;

          2. Having a history of use or desire to use eye drops for dry eye symptoms within 6
             months prior to Visit 1;

          3. Having a best corrected visual acuity (BCVA) of 0.7 logMAR or better (Snellen
             equivalent score of 20/100 or better) in each eye at Visit 1;

          4. Having a score of ≥ 40 according to the Visual Analog Scale (VAS) in at least one of
             the dry eye symptoms at Visits 1 and 2;

          5. Having a Schirmers Test score of ≤ 5 mm and ≥ 1 mm for the study eye at Visits 1 and
             2;

          6. Having a TFBUT≤ 5 seconds for the study eye at Visit 1 and 2;

          7. Having a corneal fluorescein staining score of ≥ 2 in at least one sub-area (inferior,
             superior, or central cornea), inferior corneal fluorescein staining score ≤3, and
             total corneal fluorescein staining score <10 according to the Ora Calibra® Corneal and
             Conjunctival Staining Scale for Grading of Fluorescein Staining in the study eye at
             Visits 1 and 2;

          8. Having a conjunctival redness score ≥ 1 according to the Ora Calibra® Conjunctival
             Redness for Dry Eye Scale in the study eye at Visits 1 and 2

        Exclusion Criteria:

          1. Have any clinically significant slit lamp findings at Visit 1 that may include active
             blepharitis, lid margin inflammation or active ocular allergies that require
             therapeutic treatment, and/or in the opinion of the investigator may interfere with
             study parameters; meibomian gland dysfunction which needs therapy judged by
             investigator;

          2. Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active
             ocular inflammation at Visit 1;

          3. Dry eye patients diagnosed of Sjogren's syndrome, Steven-Johnson Syndrome or dry eye
             secondary to chronic graft-versus-host disease or patients suffered from serious
             systemic autoimmune disorders (such as systemic lupus erythematosus, rheumatoid
             arthritis), who are treated with immunosuppressive biologics within 12 months or
             expect to receive immunosuppressive biologics during the study;

          4. Have any planned ocular and/or lid surgeries over the study period;

          5. Be using temporary punctal plugs within 6 months or anticipate using temporary punctal
             plugs during the study; or plan to use permanent punctal plugs; or received permanent
             punctal plugs within 3 months; or received permanent punctal plugs and had
             complications such as falloff or displacement;

          6. Have used Cyclosporin A, tacrolimus or Xiidra? within 60 days before Visit 1;

          7. Have any previous experience using HBM9036 (HL036);

          8. Be currently taking any topical ophthalmic prescription (including medications for
             glaucoma) or over-the-counter solutions(OTC), artificial tears, gels or scrubs, and
             cannot discontinue these medications for the duration of the trial (excluding
             medications allowed for the conduct of the study); the respective wash-out periods are
             required for parts of medications.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn.  The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness.  She also reports occasional joint pain.  Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease.  She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h)

Patient description (patient's own words): I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR.

Does the patient match the trial criteria? 0