Dry EyePhase 2NCT04556838

Study of VVN001 Ophthalmic Solution in Dry Eye Disease

A Phase 2 study testing VVN001 Ophthalmic Solution 1% and VVN001 Ophthalmic Solution 5% in people with Dry Eye, run by VivaVision Biotech, Inc at 1 site in United States.

Completed

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

Official record

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Trial summary

This is a Phase 2a, multi-center, double-masked, randomized, vehicle-controlled, parallel-group study designed to evaluate the safety and tolerability and to explore the efficacy activity of VVN001 ophthalmic solution versus vehicle in subjects with dry eye disease. 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?: VVN001 Ophthalmic Solution 1% and VVN001 Ophthalmic Solution 5%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 169 participants
Where: 1 siteUnited States
Study dates: 3 Dec 2020to 1 Dec 2021
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Provide written informed consent prior to any study-related procedures .
Are 18 years of age or older.
Are willing and able to follow instructions and willing to be present for the required study visits for the duration of the study.
Have a best corrected visual acuity (BCVA), using corrective lenses if necessary, in the qualifying eye(s) of +0.7 or better as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) at the screening visit and randomization visit.
Have a history of dry eye disease in both eyes
Are currently using artificial tears and have been using within 30 days of the screening visit.

Show all 10Show fewer

Have an Eye dryness score ≥40 at Visit 1 and ≥35 at Visit 2, one score for both eyes (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:
Inferior CFS (iCFS) score of ≥2 (NEI; 0-4 scale; using 0.5 unit increments)
Have a Schirmer score (without anesthesia) of ≥1 and ≤7 mm/5 min.

Who cannot join

Have a known hypersensitivity or contraindication to the IP or components of IP.
Have a Schirmer score (without anesthesia) of <1 or >7 mm/5 min in the study eye.
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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Lexitas
Durham, North Carolina, 27703

Other trials in United States

About this study

Official title: A Phase 2a, Double-Masked, Randomized, Vehicle-controlled Trial Evaluating the Safety and Efficacy Activity of 1% and 5% VVN001 Compared to Vehicle in Subjects With Dry Eye Disease

Conditions: Dry Eye
Being tested: VVN001 Ophthalmic Solution 1%, VVN001 Ophthalmic Solution 5%, 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 1%Drug
VVN001 Ophthalmic Solution 1%
VVN001 Ophthalmic Solution 5%Drug
VVN001 Ophthalmic Solution 5%
VehicleDrug
VVN001 Ophthalmic Solution Vehicle

Study groups in NCT04556838
Study group	Role	What they receive
VVN001, 1%	Experimental	VVN001, 1% ophthalmic solution Receives: Drug: VVN001 Ophthalmic Solution 1%
VVN001, 5%	Experimental	VVN001, 5% ophthalmic solution Receives: Drug: VVN001 Ophthalmic Solution 5%
Vehicle	Placebo comparator	VVN001 Ophthalmic Solution Placebo Receives: Drug: Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

Inferior Corneal Fluorescein Staining
Mean change from baseline in Inferior corneal fluorescein staining. Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -4 to +4.
Measured: Day 84

Secondary outcomes (3)

Total Corneal Fluorescein Staining
Mean change from baseline in total corneal fluorescein staining Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -20 to +20.
Measured: Day 84
Regional Corneal Fluorescein Staining
Mean change from baseline in temporal regional corneal fluorescein staining. Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -4 to +4.
Measured: Day 84
Eye Dryness
Mean Change in Eye Dryness VAS. Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -100 to +100..
Measured: Day 84

Timeline

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

3 Dec 20201 Dec 2021

First posted21 Sep 2020
Study start3 Dec 2020
Primary completion1 Dec 2021
Study completion1 Dec 2021

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
Model description: Double-masked parallel
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 169 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04556838
Sponsor's protocol ID: VVN001-CS-201
Status last verified: Dec 2023
First submitted: 14 Sep 2020
Last updated: 13 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Tauber J, Evans D, Segal B, Li XY, Shen W, Lu C, Novack GD; VVN001-CS201 Study Group. A phase 2a, double-masked, randomized, vehicle-controlled trial of VVN001 in subjects with dry eye disease. Ocul Surf. 2023 Apr;28:18-24. doi: 10.1016/j.jtos.2022.12.007. Epub 2022 Dec 29.
PubMed 36586669

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

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Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2a, Double-Masked, Randomized, Vehicle-controlled Trial Evaluating the Safety and Efficacy Activity of 1% and 5% VVN001 Compared to Vehicle in Subjects With Dry Eye Disease
ClinicalTrials.gov ID: NCT04556838
Acronym / sponsor ID: VVN001-CS-201
Conditions: Dry Eye
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 169 participants (actual)
Lead sponsor: VivaVision Biotech, IncIndustry (pharma, biotech, devices)
Study start: 3 Dec 2020 (actual)
Primary completion: 1 Dec 2021 (actual)
Study completion: 1 Dec 2021 (actual)
First posted: 21 Sep 2020 (actual)
Results: Posted 28 Feb 2023

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3
Model description: Double-masked parallel

Arm	Type	Receives
VVN001, 1%	Experimental	Drug: VVN001 Ophthalmic Solution 1%VVN001, 1% ophthalmic solution
VVN001, 5%	Experimental	Drug: VVN001 Ophthalmic Solution 5%VVN001, 5% ophthalmic solution
Vehicle	Placebo comparator	Drug: VehicleVVN001 Ophthalmic Solution Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Provide written informed consent prior to any study-related procedures .
Are 18 years of age or older.
Are willing and able to follow instructions and willing to be present for the required study visits for the duration of the study.
Have a best corrected visual acuity (BCVA), using corrective lenses if necessary, in the qualifying eye(s) of +0.7 or better as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) at the screening visit and randomization visit.
Have a history of dry eye disease in both eyes

Key exclusion criteria (3 listed)

Have a known hypersensitivity or contraindication to the IP or components of IP.
Have a Schirmer score (without anesthesia) of <1 or >7 mm/5 min in the study eye.
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.

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 1%VVN001 Ophthalmic Solution 1%	Drug	VVN001, 1%
VVN001 Ophthalmic Solution 5%VVN001 Ophthalmic Solution 5%	Drug	VVN001, 5%
VehicleVVN001 Ophthalmic Solution Vehicle	Drug	Vehicle

Primary outcome

Inferior Corneal Fluorescein Staining
Time frame: Day 84
Mean change from baseline in Inferior corneal fluorescein staining. Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -4 to +4.

3 secondary outcomes

Total Corneal Fluorescein Staining
Time frame: Day 84
Regional Corneal Fluorescein Staining
Time frame: Day 84
Eye Dryness
Time frame: Day 84

Results and safety

Results posted to the registry on 28 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VVN001, 1%	57	53
VVN001, 5%	56	53
Vehicle	56	51

Primary outcome: Inferior Corneal Fluorescein Staining

Time frame: Day 84. Mean (Standard Deviation). Unit: score on a scale

Measure	VVN001, 1% n = 54	VVN001, 5% n = 53	Vehicle n = 51
Value	-0.69 (0.77)	-.97 (0.81)	-0.72 (0.83)

Population analysed: Sample size reflects number of subjects evaluable at Day 84

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 84 days. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VVN001, 1%	0 of 56 (0%)	3 of 56 (5.4%)	0 of 57
VVN001, 5%	0 of 57 (0%)	6 of 57 (10.5%)	0 of 56
Vehicle	0 of 56 (0%)	2 of 56 (3.6%)	0 of 56

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 36586669Tauber J, Evans D, Segal B, Li XY, Shen W, Lu C, Novack GD; VVN001-CS201 Study Group. A phase 2a, double-masked, randomized, vehicle-controlled trial of VVN001 in subjects with dry eye disease. Ocul Surf. 2023 Apr;28:18-24. doi: 10.1016/j.jtos.2022.12.007. Epub 2022 Dec 29.
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 2 study testing VVN001 Ophthalmic Solution 1% and VVN001 Ophthalmic Solution 5% in people with Dry Eye, run by VivaVision Biotech, Inc 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 10 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 13 Dec 2023. 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 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 28 Feb 2023). 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 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?

On the ClinicalTrials.gov record for NCT04556838, 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 13 Dec 2023.