- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04633213
A Study Evaluating HBM9036 Efficacy and Safety on Moderate to Severe Dry Eye
February 23, 2023 updated by: Harbour BioMed (Guangzhou) Co. Ltd.
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
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
674
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zuguo Liu, Doctor
- Phone Number: 0592-2109193 86-18959289999
- Email: zuguoliu@xmu.edu.cn
Study Locations
-
-
Fujian
-
Xiamen, Fujian, China, 361100
- Recruiting
- Xiamen Eye Center of Xiamen University
-
Principal Investigator:
- Zuguo Liu
-
Contact:
- Zuguo Liu
- Phone Number: +86 18959289999
- Email: zuguoliu@xmu.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HBM9036 0.25% Ophthalmic Solution
HBM9036, Ophthalmic Solution, twice a day, in the morning and evening
|
Ophthalmic Solution
|
Placebo Comparator: Placebo Ophthalmic Solution
placebo, Ophthalmic Solution, twice a day, in the morning and evening
|
Ophthalmic Solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in total corneal staining scores (upper, central and lower cornea) of the study eye
Time Frame: 8 weeks
|
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.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Zuguo Liu, Doctor, Xiamen Eye Center Affiliated to Xiamen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 24, 2021
Primary Completion (Actual)
December 31, 2022
Study Completion (Anticipated)
April 7, 2023
Study Registration Dates
First Submitted
November 11, 2020
First Submitted That Met QC Criteria
November 11, 2020
First Posted (Actual)
November 18, 2020
Study Record Updates
Last Update Posted (Actual)
February 24, 2023
Last Update Submitted That Met QC Criteria
February 23, 2023
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9036.2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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