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

Phase 2

Completed

Brief Summary: The purpose of this study is to compare the efficacy and safety of HBM9036 Ophthalmic Solution versus placebo in the treatment of dry eye

Detailed Description: 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 .

Recruitment & Eligibility

Inclusion Criteria

Not provided

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;

Arm && Interventions

Group	Intervention	Description
HBM9036 0.25% Ophthalmic Solution	HBM9036 0.25% Ophthalmic Solution	HBM9036, Ophthalmic Solution, twice a day, in the morning and evening
Placebo Ophthalmic Solution	placebo	placebo, Ophthalmic Solution, twice a day, in the morning and evening

Primary Outcome Measures

Name	Time	Method
Inferior Corneal Staining (ICS) Score	8 weeks	Inferior corneal staining score, assessed by Ora Calibra® Corneal and Conjunctival Fluorescein Staining Scale (0-4 point, higher is worse) Change from baseline in change from pre- to post- CAE at Visit 6 (higher is worse)

Secondary Outcome Measures

Name	Time	Method
Ocular Discomfort Score	8 weeks	Ocular Discomfort Score, assessed by Ora Calibra® Ocular Discomfort Scale (0-4 point, higher is worse) Change from baseline in pre-CAE Ocular Discomfort Score at Visit 6 (higher is worse)