Dry EyePhase 2NCT04092907

A Study Evaluating the Efficacy and Safety on Moderate to Severe Dry Eye

A Phase 2 study testing HBM9036 0.25% Ophthalmic Solution in people with Dry Eye, run by Harbour BioMed (Guangzhou) Co. Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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 Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
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: 100 participants
Where: 1 siteChina
Study dates: 22 Mar 2019to 10 Jul 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Trial locations and contacts

1 site in 1 country.

China1 site

Qingdao Eye Hospital
Qingdao, Shandong, 266000

Other trials in China

About this study

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

The purpose of this study is to compare the efficacy and safety of HBM9036 Ophthalmic Solution versus placebo in the treatment of dry eye

Read the 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 .

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 groups in NCT04092907
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.

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)
Measured: 8 weeks

Secondary outcomes (1)

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)
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Mar 201910 Jul 2019

First posted17 Sep 2019
Study start22 Mar 2019
Primary completion3 Jul 2019
Study completion10 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04092907
Sponsor's protocol ID: 9036.1
Status last verified: Jul 2021
First submitted: 9 Sep 2019
Last updated: 11 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 35192105

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
Meibomian Gland Dysfunction, Dry Eye Disease
RecruitingPhase 2
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease
Sjogren's Syndrome
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
Not yet recruitingEarly Phase 1
a Novel siRNA Eyedrops for DED Treatment
Dry Eye

All Dry Eye trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04092907
Acronym / sponsor ID: 9036.1
Conditions: Dry Eye
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Harbour BioMed (Guangzhou) Co. Ltd.Industry (pharma, biotech, devices)
Study start: 22 Mar 2019 (actual)
Primary completion: 3 Jul 2019 (actual)
Study completion: 10 Jul 2019 (actual)
First posted: 17 Sep 2019 (actual)
Results: Posted 11 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (3 listed)

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;

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

Inferior Corneal Staining (ICS) Score
Time frame: 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)

1 secondary outcome

Ocular Discomfort Score
Time frame: 8 weeks

Results and safety

Results posted to the registry on 11 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HBM9036 0.25% Ophthalmic Solution	50	48
Placebo Ophthalmic Solution	50	50

Primary outcome: Inferior Corneal Staining (ICS) Score

Time frame: 8 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	HBM9036 0.25% Ophthalmic Solution n = 47	Placebo Ophthalmic Solution n = 48
Value	1.8 (0.44)	1.9 (0.46)

Population analysed: The analysis population is per-protocol population, which excluded a few patients.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From start of the first study drug administration up to Day 57 or Early termination (ET). Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HBM9036 0.25% Ophthalmic Solution	0 of 0	14 of 50 (28%)	0 of 50
Placebo Ophthalmic Solution	0 of 0	14 of 50 (28%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35192105Dong 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.
Individual participant dataSharing planned: No

Related trials for Dry Eye

Active, not recruiting
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
Meibomian Gland Dysfunction, Dry Eye Disease
RecruitingPhase 2
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease
Sjogren's Syndrome
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
Not yet recruitingEarly Phase 1
a Novel siRNA Eyedrops for DED Treatment
Dry Eye

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.

Lixin XIE, Academician principal investigator

QINGDAO EYE HOSPITAL

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 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 4 inclusion and 3 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 11 Aug 2021. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Inferior Corneal Staining (ICS) Score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04092907, which also lists 1 linked publication.

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 11 Aug 2021.