Dry EyePhase 3NCT06360133
Study of 5% VVN001 Ophthalmic Solution in Dry Eye Disease
A Phase 3 study testing VVN001 Ophthalmic Solution, 5% in people with Dry Eye, run by VivaVision Biotech, Inc at 1 site in China.
Trial summary
This is a Phase 3, randomized, double-Masked, vehicle-controlled, multi-center study designed to evaluate the safety and efficacy of 5% VVN001 Ophthalmic Solution versus vehicle in Chinese subjects with dry eye disease. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Dry Eye
- What is being tested?
- VVN001 Ophthalmic Solution, 5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 30 Apr 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provided written informed consent prior to any study-related procedures.
- Are between 30 and 80 years of age.
- Have a history of dry eye disease in both eyes.
- Have been using artificial tears within 30 days of the screening visit
- Have an Eye dryness score ≥50 (0-100 point VAS)
- Have ongoing dry eye disease in the same eye or both eyes, as defined by all of the following criteria in the study eye and the same eye at Visit 1 and Visit 2: 1) total CFS (tCFS) score ≥6; 2) any subregion CS score ≥2.5; 3) Schirmer score (without anesthesia) ≥1 and ≤7 mm/5 min.
- Have a BCVA in the study eye of ≥4.3 (Standard for Logarithmic Visual Acuity Charts, 5-mark record).
Who cannot join
- Have a known hypersensitivity or contraindication to the IP or components of IP.
- Have history of uncontrolled glaucoma, IOP over 21 mmHg in either eye at the screening visit or are being treated with eye drops for glaucoma in the study eye. Or the subject has had laser or surgery for glaucoma in the study eye within 90 days of the study.
- Woman of childbearing potential (WOCP) who are pregnant, lactating, or preparing for pregnant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Eye & Ent Hospital of Fudan University
Shanghai, Shanghai Municipality
About this study
Official title: A Phase 3, Randomized, Double-Masked, Vehicle-controlled, Multi-center Study Evaluating the Safety and Efficacy of 5% VVN001 in Chinese Subjects With Dry Eye Disease
This is a Phase 3, randomized, double-Masked, vehicle-controlled, multi-center study designed to evaluate the safety and efficacy of 5% VVN001 Ophthalmic Solution versus vehicle in Chinese subjects with dry eye disease.
- Conditions
- Dry Eye
- Being tested
- VVN001 Ophthalmic Solution, 5%, VVN001 Ophthalmic Solution, Vehicle
- 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.
VVN001 Ophthalmic Solution, 5%Drug
VVN001 Ophthalmic Solution, 5%
VVN001 Ophthalmic Solution, VehicleDrug
VVN001 Ophthalmic Solution, Vehicle
| Study group | Role | What they receive |
|---|---|---|
| VVN001 | Experimental | VVN001 Ophthalmic Solution, 5% Receives: Drug: VVN001 Ophthalmic Solution, 5% |
| Vehicle | Placebo comparator | VVN001 Ophthalmic Solution, Vehicle Receives: Drug: VVN001 Ophthalmic Solution, Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Fluorescein Staining
Mean Change from baseline (Visit 2) to Day84 (Visit 6) in total corneal fluorescein staining (tCFS) using modified NEI/Industry Workshop (0-4 scale, using 0.5 unit increments).
Measured: Day 84
Secondary outcomes (1)
Eye Dryness
Mean Change from baseline (Visit 2) to Day 84 (Visit 6) in the individual symptom of eye dryness (0~100 VAS scale).
Measured: Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start1 Apr 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
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
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VivaVision Biotech, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xinghuai Sun, Principal investigator, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360133
- Sponsor's protocol ID
- VVN001-CCS-301
- Status last verified
- Aug 2026
- First submitted
- 6 Apr 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Masked, Vehicle-controlled, Multi-center Study Evaluating the Safety and Efficacy of 5% VVN001 in Chinese Subjects With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT06360133
- Acronym / sponsor ID
- VVN001-CCS-301
- Conditions
- Dry Eye
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- VivaVision Biotech, IncIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 11 Apr 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.
This is a Phase 3, randomized, double-Masked, vehicle-controlled, multi-center study designed to evaluate the safety and efficacy of 5% VVN001 Ophthalmic Solution versus vehicle in Chinese subjects with dry eye disease.
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 |
|---|---|---|
| VVN001 | Experimental | Drug: VVN001 Ophthalmic Solution, 5%VVN001 Ophthalmic Solution, 5% |
| Vehicle | Placebo comparator | Drug: VVN001 Ophthalmic Solution, VehicleVVN001 Ophthalmic Solution, Vehicle |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provided written informed consent prior to any study-related procedures.
- Are between 30 and 80 years of age.
- Have a history of dry eye disease in both eyes.
- Have been using artificial tears within 30 days of the screening visit
- Have an Eye dryness score ≥50 (0-100 point VAS)
Key exclusion criteria (3 listed)
- Have a known hypersensitivity or contraindication to the IP or components of IP.
- Have history of uncontrolled glaucoma, IOP over 21 mmHg in either eye at the screening visit or are being treated with eye drops for glaucoma in the study eye. Or the subject has had laser or surgery for glaucoma in the study eye within 90 days of the study.
- Woman of childbearing potential (WOCP) who are pregnant, lactating, or preparing for pregnant.
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 |
|---|---|---|
| VVN001 Ophthalmic Solution, 5%VVN001 Ophthalmic Solution, 5% | Drug | VVN001 |
| VVN001 Ophthalmic Solution, VehicleVVN001 Ophthalmic Solution, Vehicle | Drug | Vehicle |
Primary outcome
Corneal Fluorescein Staining
Time frame: Day 84
Mean Change from baseline (Visit 2) to Day84 (Visit 6) in total corneal fluorescein staining (tCFS) using modified NEI/Industry Workshop (0-4 scale, using 0.5 unit increments).
1 secondary outcome
Eye Dryness
Time frame: Day 84
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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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.
Xinghuai Sun principal investigator
Eye & ENT Hospital of Fudan 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 VVN001 Ophthalmic Solution, 5% in people with Dry Eye, run by VivaVision Biotech, Inc 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 7 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: looking for participants now, as of the sponsor's last update on 20 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline Lu (86-18816562189, caroline.lu@vivavisionbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal Fluorescein Staining (time frame: Day 84). 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 20 Aug 2026.