Dry EyePhase 3NCT04633213
A Study Evaluating HBM9036 Efficacy and Safety on Moderate to Severe Dry Eye
A Phase 3 study testing HBM9036 0.25% Ophthalmic Solution in people with Dry Eye, run by Harbour BioMed (Guangzhou) Co. Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- HBM9036 0.25% Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 577 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2021to 7 Aug 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Dry Eye
- Being tested
- HBM9036 0.25% Ophthalmic Solution, Placebo
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBM9036 0.25% Ophthalmic SolutionDrug
Ophthalmic Solution
PlaceboDrug
Ophthalmic Solution
| Study group | Role | What they receive |
|---|---|---|
| HBM9036 0.25% Ophthalmic Solution | Experimental | HBM9036, Ophthalmic Solution, twice a day, in the morning and evening Receives: Drug: HBM9036 0.25% Ophthalmic Solution |
| Placebo Ophthalmic Solution | Placebo comparator | placebo, Ophthalmic Solution, twice a day, in the morning and evening Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start25 Feb 2021
- Primary completion7 Aug 2022
- Study completion7 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 577 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harbour BioMed (Guangzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zuguo Liu, Doctor, Principal investigator, Xiamen Eye Center Affiliated to Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633213
- Sponsor's protocol ID
- 9036.2
- Status last verified
- Aug 2022
- First submitted
- 11 Nov 2020
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04633213
- Acronym / sponsor ID
- 9036.2
- Conditions
- Dry Eye
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 577 participants (actual)
- Lead sponsor
- Harbour BioMed (Guangzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 7 Aug 2022 (actual)
- Study completion
- 7 Aug 2022 (actual)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HBM9036 0.25% Ophthalmic Solution | Experimental | Drug: HBM9036 0.25% Ophthalmic SolutionHBM9036, Ophthalmic Solution, twice a day, in the morning and evening |
| Placebo Ophthalmic Solution | Placebo comparator | Drug: Placeboplacebo, Ophthalmic Solution, twice a day, in the morning and evening |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBM9036 0.25% Ophthalmic SolutionOphthalmic Solution | Drug | HBM9036 0.25% Ophthalmic Solution |
| PlaceboOphthalmic Solution | Drug | Placebo Ophthalmic Solution |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zuguo Liu, Doctor principal investigator
Xiamen Eye Center Affiliated to Xiamen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HBM9036 0.25% Ophthalmic Solution in people with Dry Eye, run by Harbour BioMed (Guangzhou) Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in total corneal staining scores (upper, central and lower cornea) of the study eye (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.