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

Study Overview
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Brief Summary
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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
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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 .

Official Title
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A Phase 2, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of HBM9036 Ophthalmic Solution Versus Placebo in Subjects With Moderate to Severe Dry Eye

Conditions
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Dry Eye

Intervention / Treatment
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* Drug: HBM9036 0.25% Ophthalmic Solution
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HBM9036 0.25% Ophthalmic Solution<br>HBM9036, Ophthalmic Solution, twice a day, in the morning and evening | Drug: HBM9036 0.25% Ophthalmic Solution<br>* Ophthalmic Solution<br>|
| Placebo Comparator: Placebo Ophthalmic Solution<br>placebo, Ophthalmic Solution, twice a day, in the morning and evening | Drug: placebo<br>* Ophthalmic Solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inferior Corneal Staining (ICS) Score | 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) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Discomfort Score | 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) | 8 weeks |