A Study Evaluating the Efficacy and Safety on Moderate to Severe Dry Eye

HBM9036 is a molecularly engineered tumor necrosis factor receptor 1 (TNFR1) fragment.

A total of 100 subjects are expected to be randomized. Subjects will be randomized 1:1 at Visit 2 to HBM9036 Ophthalmic Solution or placebo group, bilaterally BID for eight weeks. The primary efficacy endpoint is sign changes from baseline in change from pre- to post-CAE inferior corneal staining score (ICSS) of the study eye evaluated at week 8 .

Inclusion criteria

• Have a history of use eye drops for dry eye symptoms within 6 months of Visit 1 or desire to use eye drops;
• Have in the study eye a Schirmer's Test score of ≤ 10 mm and ≥ 1 mm at Visits 1 and 2;
• Be willing and can adjust current treatment for dry eye according to the protocol, judged by the Investigator;
• Must be willing to complete all study assessments required by the protocol.

Exclusion criteria

• Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
• Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months, or had femtosecond small incision lenticule extraction (SMILE) within the last 12 months, or had phacoemulsification within the last 3 months, or had dry eye or aggravation of dry eye caused by other ocular operations has not been stable;
• Have used ophthalmic cyclosporine A, tacrolimus or Xiidra® within 60 days prior to Visit 1;