Dry Eye
Conditions
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 .
Interventions
Ophthalmic Solution
DRUGplacebo
Ophthalmic Solution
Sponsors
Harbour BioMed (Guangzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Have a history of use eye drops for dry eye symptoms within 6 months of Visit 1 or desire to use eye drops; 2. Have in the study eye a Schirmer's Test score of ≤ 10 mm and ≥ 1 mm at Visits 1 and 2; 3. Be willing and can adjust current treatment for dry eye according to the protocol, judged by the Investigator; 4. Must be willing to complete all study assessments required by the protocol.
Exclusion criteria
1. Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1; 2. 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; 3. Have used ophthalmic cyclosporine A, tacrolimus or Xiidra® within 60 days prior to Visit 1;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HBM9036 0.25% Ophthalmic Solution HBM9036, Ophthalmic Solution, twice a day, in the morning and evening
HBM9036 0.25% Ophthalmic Solution: Ophthalmic Solution | 50 |
| Placebo Ophthalmic Solution placebo, Ophthalmic Solution, twice a day, in the morning and evening
placebo: Ophthalmic Solution | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | HBM9036 0.25% Ophthalmic Solution | Placebo Ophthalmic Solution | Total |
|---|---|---|---|
| Age, Continuous | 41.4 years STANDARD_DEVIATION 11.19 | 43.9 years STANDARD_DEVIATION 9.15 | 42.6 years STANDARD_DEVIATION 10.25 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 25 Participants | 32 Participants | 57 Participants |
| Sex: Female, Male Male | 25 Participants | 18 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 14 / 50 | 14 / 50 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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)
Time frame: 8 weeks
Population: The analysis population is per-protocol population, which excluded a few patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HBM9036 0.25% Ophthalmic Solution | Inferior Corneal Staining (ICS) Score | 1.8 units on a scale | Standard Deviation 0.44 |
| Placebo Ophthalmic Solution | Inferior Corneal Staining (ICS) Score | 1.9 units on a scale | Standard Deviation 0.46 |
Secondary
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)
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HBM9036 0.25% Ophthalmic Solution | Ocular Discomfort Score | 2.94 units on a scale | Standard Deviation 0.791 |
| Placebo Ophthalmic Solution | Ocular Discomfort Score | 3.10 units on a scale | Standard Deviation 0.692 |