A Study Evaluating HBM9036 Efficacy and Safety on Moderate to Severe Dry Eye
Primary Purpose
Dry Eye
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
HBM9036 0.25% Ophthalmic Solution
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility Criteria
Inclusion Criteria:
- At least 6 months history of any dry eye symptoms;
- Must use or feel the need to use any types of eye drops to treat dry eye disease symptoms within 6 months prior to Screening Visit;
- Best corrected visual acuity (BCVA) ≥ logMAR+0.7 as assessed according to the Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at Screening Visit;
- At least 1 eye dryness score ≥ 40mm measured by 100mm Visual Analogue Scale (VAS) at Screening Visit;
- Schirmer's test score (anesthetized) ≥ 1mm and ≤ 10mm in the study eye at Screening Visit;
- Average tear film breakup time (TFBUT) ≤5 seconds in the study eye at Screening Visit;
- Total corneal fluorescein staining score ≥ 5.5 according to the Ora Calibra Corneal and Conjunctival Staining Scale at least in the study eye at Screening and Baseline Visits;
- Conjunctival redness score ≥1 according to the Ora Calibra Conjunctival Redness Scale at least in the study eye at Screening Visit.
Exclusion Criteria:
- At Screening Visit, Subjects observed by investigator with any clinically significant signs including active blepharitis and ocular allergies. Patients with meibomian gland dysfunction that need treatment;
- Currently active ocular infection (bacterial, viral, or fungal) or any ocular surface inflammation;
- Patients whose dry eye disease secondary to Sjogren's syndrome, Steven-Johnson Syndrome or chronic graft versus host disease, or patients suffered from serious autoimmune disorders such as systemic lupus erythematosus or rheumatoid arthritis, If their systemic disease are instable or drug application changed such as the type or dose of immunosuppressive biologics had been adjusted within 3 months or had drug withdrawal within 1 month or expected to have their drugs adjusted or discontinued during the study;
- Planning to undergo any ocular or eyelid surgery;
- Patients suffered from insertion of temporary lacrimal plug surgery within 6 months or insertion of permanent lacrimal plug surgery within 3 months. Or planning to undergo insertion of lacrimal plug surgery during the study;
- Use of Cyclosporine A, Tacrolimus or Xiidra within 60 days prior to Screening Visit;
- History of HBM9036 (HL036) use;
- Currently use of prescription (including but not limited to antiglaucoma drops) or OTC drugs that locally applied to eyes, artificial tears, ophthalmic gel and eye rinse that cannot be interrupted during the study (excluding medications allowed in this study); pharmacological wash-out periods are required for some drugs.
Sites / Locations
- Xiamen Eye Center of Xiamen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
HBM9036 0.25% Ophthalmic Solution
Placebo Ophthalmic Solution
Arm Description
HBM9036, Ophthalmic Solution, twice a day, in the morning and evening
placebo, Ophthalmic Solution, twice a day, in the morning and evening
Outcomes
Primary Outcome Measures
Change from baseline in total corneal staining scores (upper, central and lower cornea) of the study eye
Total corneal staining score (TCSS; superior, central, and inferior regions) of study eye evaluated by Ora Calibra® Corneal and Conjunctival Staining Scale for Grading of Fluorescein Staining at Visit 5/Day 57, change from baseline Score: From 0-12, a higher score means a worse outcome.
Secondary Outcome Measures
Full Information
NCT ID
NCT04633213
First Posted
November 11, 2020
Last Updated
February 23, 2023
Sponsor
Harbour BioMed (Guangzhou) Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04633213
Brief Title
A Study Evaluating HBM9036 Efficacy and Safety on Moderate to Severe Dry Eye
Official Title
A Phase 3, Multicenter, Randomized, Double-Blinded and Placebo-Controlled Study Evaluating the Efficacy and Safety of 0.25% HBM9036 (HL036) Ophthalmic Solution Compared to Placebo in Chinese Subjects With Moderate and Severe Dry Eye
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
April 7, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Harbour BioMed (Guangzhou) Co. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this study is to compare the safety and efficacy of 0.25% HBM9036 (HL036) Ophthalmic Solution to placebo for the treatment of the Chinese subjects with moderate and severe dry eye.
Detailed Description
Inhibitors for tumor necrosis factor (TNF) have been widely used in clinical practice. Such class of medications have been approved for rheumatoid arthritis, ulcerative colitis, and uveitis. HBM9036 (HL036) is a molecularly engineered TNFR1 fragment, and molecule fragmentation and engineering techniques are applied for enhanced tissue distribution, increased stability and potency. In multiple early stage studies including preclinical studies, HBM9036 (HL036) has demonstrated the safety and efficacy in the therapy for moderate and severe dry eye. As a phase 3 confirmational study, this study is to evaluate the safety and efficacy of 0.25% HBM9036 (HL036) ophthalmic solution compared to placebo in Chinese subjects with moderate and severe dry eye.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
674 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HBM9036 0.25% Ophthalmic Solution
Arm Type
Experimental
Arm Description
HBM9036, Ophthalmic Solution, twice a day, in the morning and evening
Arm Title
Placebo Ophthalmic Solution
Arm Type
Placebo Comparator
Arm Description
placebo, Ophthalmic Solution, twice a day, in the morning and evening
Intervention Type
Drug
Intervention Name(s)
HBM9036 0.25% Ophthalmic Solution
Intervention Description
Ophthalmic Solution
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Ophthalmic Solution
Primary Outcome Measure Information:
Title
Change from baseline in total corneal staining scores (upper, central and lower cornea) of the study eye
Description
Total corneal staining score (TCSS; superior, central, and inferior regions) of study eye evaluated by Ora Calibra® Corneal and Conjunctival Staining Scale for Grading of Fluorescein Staining at Visit 5/Day 57, change from baseline Score: From 0-12, a higher score means a worse outcome.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 6 months history of any dry eye symptoms;
Must use or feel the need to use any types of eye drops to treat dry eye disease symptoms within 6 months prior to Screening Visit;
Best corrected visual acuity (BCVA) ≥ logMAR+0.7 as assessed according to the Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at Screening Visit;
At least 1 eye dryness score ≥ 40mm measured by 100mm Visual Analogue Scale (VAS) at Screening Visit;
Schirmer's test score (anesthetized) ≥ 1mm and ≤ 10mm in the study eye at Screening Visit;
Average tear film breakup time (TFBUT) ≤5 seconds in the study eye at Screening Visit;
Total corneal fluorescein staining score ≥ 5.5 according to the Ora Calibra Corneal and Conjunctival Staining Scale at least in the study eye at Screening and Baseline Visits;
Conjunctival redness score ≥1 according to the Ora Calibra Conjunctival Redness Scale at least in the study eye at Screening Visit.
Exclusion Criteria:
At Screening Visit, Subjects observed by investigator with any clinically significant signs including active blepharitis and ocular allergies. Patients with meibomian gland dysfunction that need treatment;
Currently active ocular infection (bacterial, viral, or fungal) or any ocular surface inflammation;
Patients whose dry eye disease secondary to Sjogren's syndrome, Steven-Johnson Syndrome or chronic graft versus host disease, or patients suffered from serious autoimmune disorders such as systemic lupus erythematosus or rheumatoid arthritis, If their systemic disease are instable or drug application changed such as the type or dose of immunosuppressive biologics had been adjusted within 3 months or had drug withdrawal within 1 month or expected to have their drugs adjusted or discontinued during the study;
Planning to undergo any ocular or eyelid surgery;
Patients suffered from insertion of temporary lacrimal plug surgery within 6 months or insertion of permanent lacrimal plug surgery within 3 months. Or planning to undergo insertion of lacrimal plug surgery during the study;
Use of Cyclosporine A, Tacrolimus or Xiidra within 60 days prior to Screening Visit;
History of HBM9036 (HL036) use;
Currently use of prescription (including but not limited to antiglaucoma drops) or OTC drugs that locally applied to eyes, artificial tears, ophthalmic gel and eye rinse that cannot be interrupted during the study (excluding medications allowed in this study); pharmacological wash-out periods are required for some drugs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zuguo Liu, Doctor
Phone
86-18959289999
Ext
0592-2109193
Email
zuguoliu@xmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zuguo Liu, Doctor
Organizational Affiliation
Xiamen Eye Center Affiliated to Xiamen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiamen Eye Center of Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361100
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zuguo Liu
Phone
+86 18959289999
Email
zuguoliu@xmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Zuguo Liu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study Evaluating HBM9036 Efficacy and Safety on Moderate to Severe Dry Eye
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