Dry EyePhase 3VELOS-4NCT06400589
A Study to Evaluate the Efficacy and Safety of Tanfanercept (HL036) in Dry Eye Disease
A Phase 3 study testing tanfanercept in people with Dry Eye, run by HanAll BioPharma Co., Ltd. at 1 site in United States.
Trial summary
The objectives of this study are to compare the efficacy and safety of tanfanercept ophthalmic solution 0.25% and 1.0% to vehicle for the treatment of DED. 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?
- tanfanercept
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to Aug 2025
- 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
- Are at least 18 years of age
- Provide written informed consent
- Are willing to attend all study visits and able to comply with study procedures and assessments
- Have a self-reported history of DED (OU) for at least 6 months prior to Visit 1
Who cannot join
- Have an uncontrolled systemic disease
- Have been exposed to an investigational drug or device within 30 days or 5 half-lives prior to Visit 1, whichever is longer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-Masked and Vehicle-Controlled Study Evaluating the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution 0.25% and 1.0% Compared to Vehicle in Participants With Dry Eye Disease (VELOS-4)
The objectives of this study are to compare the efficacy and safety of tanfanercept ophthalmic solution 0.25% and 1.0% to vehicle for the treatment of DED.
Read the detailed description
The purpose of this research study is to test the safety and effectiveness (how well the drug works) of Tanfanercept ophthalmic solution 0.25% and Tanfanercept ophthalmic solution 1% against vehicle (no active treatment). Effectiveness will be measured by the improvement in Schirmer Test results (a test to see how many tears you produce), reduction of dry eye symptoms, eye redness (conjunctival redness), and eye surface irritation (corneal staining, conjunctival staining). Eye safety assessments will also be performed.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tanfanerceptDrug
TNF inhibitor
VehicleDrug
Same composition as tanfanercept but without the active ingredient
| Study group | Role | What they receive |
|---|---|---|
| 0.25% tanfanercept | Experimental | 0.25% tanfanercept ou bid for 12 weeks Receives: Drug: tanfanercept |
| 1.0% tanfanercept | Experimental | 1.0% tanfanercept ou bid for 12 weeks Receives: Drug: tanfanercept |
| Vehicle | Placebo comparator | Vehicle ou bid for 12 weeks Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Schirmer Test
The proportion of participants with improvement from baseline in unanesthetized Schirmer
Measured: 12 weeks
Secondary outcomes (5)
Schirmer Test
Change from baseline in unanesthetized Schirmer test score
Measured: 2 weeks, 4 weeks, 8 weeks, 12 weeks
Symptom Assessment in Dry Eye
Change from baseline in Symptom Assessment in Dry Eye
Measured: 2 weeks, 4 weeks, 8 weeks, 12 weeks
VAS
Change from baseline in Eye dryness, burning/stinging, itching, foreign body sensation, eye discomfort, photophobia, and pain on the visual analog scale (VAS)
Measured: 2 weeks, 4 weeks, 8 weeks, 12 weeks
Conjunctival redness
Change from baseline in conjunctival redness on BHVI bulbar redness scale
Measured: 2 weeks, 4 weeks, 8 weeks, 12 weeks
Corneal staining
Change from baseline in corneal staining on NEI scale
Measured: 2 weeks, 4 weeks, 8 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start1 May 2024
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Why it stopped: Logistical issue
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
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HanAll BioPharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400589
- Sponsor's protocol ID
- HL036-DED-US-P303
- Acronym
- VELOS-4
- Status last verified
- May 2024
- First submitted
- 29 Apr 2024
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-Masked and Vehicle-Controlled Study Evaluating the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution 0.25% and 1.0% Compared to Vehicle in Participants With Dry Eye Disease (VELOS-4)
- ClinicalTrials.gov ID
- NCT06400589
- Acronym / sponsor ID
- VELOS-4 / HL036-DED-US-P303
- Conditions
- Dry Eye
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Logistical issue
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- HanAll BioPharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 May 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 6 May 2024 (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 objectives of this study are to compare the efficacy and safety of tanfanercept ophthalmic solution 0.25% and 1.0% to vehicle for the treatment of DED.
Detailed description
The purpose of this research study is to test the safety and effectiveness (how well the drug works) of Tanfanercept ophthalmic solution 0.25% and Tanfanercept ophthalmic solution 1% against vehicle (no active treatment). Effectiveness will be measured by the improvement in Schirmer Test results (a test to see how many tears you produce), reduction of dry eye symptoms, eye redness (conjunctival redness), and eye surface irritation (corneal staining, conjunctival staining). Eye safety assessments will also be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.25% tanfanercept | Experimental | Drug: tanfanercept0.25% tanfanercept ou bid for 12 weeks |
| 1.0% tanfanercept | Experimental | Drug: tanfanercept1.0% tanfanercept ou bid for 12 weeks |
| Vehicle | Placebo comparator | Drug: VehicleVehicle ou bid for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are at least 18 years of age
- Provide written informed consent
- Are willing to attend all study visits and able to comply with study procedures and assessments
- Have a self-reported history of DED (OU) for at least 6 months prior to Visit 1
Key exclusion criteria (2 listed)
- Have an uncontrolled systemic disease
- Have been exposed to an investigational drug or device within 30 days or 5 half-lives prior to Visit 1, whichever is longer
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 |
|---|---|---|
| tanfanerceptTNF inhibitor | Drug | 0.25% tanfanercept, 1.0% tanfanercept |
| VehicleSame composition as tanfanercept but without the active ingredient | Drug | Vehicle |
Primary outcome
Schirmer Test
Time frame: 12 weeks
The proportion of participants with improvement from baseline in unanesthetized Schirmer
5 secondary outcomes
Schirmer Test
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks
Symptom Assessment in Dry Eye
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks
VAS
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks
Conjunctival redness
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks
Corneal staining
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 tanfanercept in people with Dry Eye, run by HanAll BioPharma Co., Ltd. at 1 site in United States.
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 2 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: paused, as of the sponsor's last update on 31 May 2024. 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 United States. 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?
Results are not available in the source record.
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?
Schirmer Test (time frame: 12 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 31 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.