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
Overview
- Phase
- Phase 2
- Intervention
- HBM9036 0.25% Ophthalmic Solution
- Conditions
- Dry Eye
- Sponsor
- Harbour BioMed (Guangzhou) Co. Ltd.
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Inferior Corneal Staining (ICS) Score
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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 .
Investigators
Eligibility Criteria
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;
Arms & Interventions
HBM9036 0.25% Ophthalmic Solution
HBM9036, Ophthalmic Solution, twice a day, in the morning and evening
Intervention: HBM9036 0.25% Ophthalmic Solution
Placebo Ophthalmic Solution
placebo, Ophthalmic Solution, twice a day, in the morning and evening
Intervention: placebo
Outcomes
Primary Outcomes
Inferior Corneal Staining (ICS) Score
Time Frame: 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 Outcomes
- Ocular Discomfort Score(8 weeks)