Back to resultsA Study Evaluating the Efficacy and Safety on Moderate to Severe Dry Eye
Primary Purpose
Dry Eye
Status
Completed
Phase
Phase 2
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
- 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;
Sites / Locations
- Qingdao Eye Hospital
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
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)
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT04092907
First Posted
September 9, 2019
Last Updated
July 20, 2021
Sponsor
Harbour BioMed (Guangzhou) Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04092907
Brief Title
A Study Evaluating the Efficacy and Safety on Moderate to Severe Dry Eye
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 22, 2019 (Actual)
Primary Completion Date
July 3, 2019 (Actual)
Study Completion Date
July 10, 2019 (Actual)
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
5. Study Description
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 .
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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
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
Inferior Corneal Staining (ICS) Score
Description
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
Secondary Outcome Measure Information:
Title
Ocular Discomfort Score
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lixin XIE, Academician
Organizational Affiliation
QINGDAO EYE HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qingdao Eye Hospital
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35192105
Citation
Dong Y, Wang S, Cong L, Zhang T, Cheng J, Yang N, Qu X, Li D, Zhou X, Wang H, Lee M, Wang M, Chen S, Ousler GW, Chen X, Xie L. TNF-alpha inhibitor tanfanercept (HBM9036) improves signs and symptoms of dry eye in a phase 2 trial in the controlled adverse environment in China. Int Ophthalmol. 2022 Aug;42(8):2459-2472. doi: 10.1007/s10792-022-02245-1. Epub 2022 Feb 22.
Results Reference
derived
Learn more about this trial
A Study Evaluating the Efficacy and Safety on Moderate to Severe Dry Eye
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