Glaucoma, Open-AnglePhase 2NCT05451329
A Phase 2 Double-masked Study of VVN539 in Subjects With Elevated Intraocular Pressure
A Phase 2 study testing VVN539 Ophthalmic Solution 0.02% and VVN539 Ophthalmic Solution 0.04% in people with Glaucoma, Open-Angle, run by VivaVision Biotech, Inc at 1 site in United States.
Trial summary
This is a prospective, parallel-comparison, multi-center, double-masked, randomized, vehicle-controlled dose-response study assessing the safety and ocular hypotensive efficacy of VVN539 in subjects with POAG or OHT. Three different dosing regimens (once a day [q.d.] in the morning, q.d. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Open-Angle
- What is being tested?
- VVN539 Ophthalmic Solution 0.02% and VVN539 Ophthalmic Solution 0.04%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2022to 22 Dec 2022
- 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
- 18 years of age or older.
- Diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes that are untreated, or if treated, in the opinion of the investigator are well controlled on 2 or fewer ocular hypotensive medications prior to Visit 1.
- Unmedicated intraocular pressure of ≥ 22 mm Hg and ≤ 36 mm Hg in the study eye, with no more than 5 mm Hg inter-eye difference at 08:00AM and 10:00AM at Visit 2.
- Corrected visual acuity in each eye +1.0 or better by Early Treatment Diabetic Retinopathy Scale in each eye (equivalent to Snellen 20/200)
Who cannot join
- Known hypersensitivity to any kinase inhibitors, any excipient or preservative of the formulation or to topical anesthetics or fluorescein.
- Unmedicated IOP of > 36 mm Hg in either eye at any time point at Visit 2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Double-masked, Randomized, Vehicle-controlled, Dose-response Study Assessing the Safety and Ocular Hypotensive Efficacy of VVN539 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
This is a prospective, parallel-comparison, multi-center, double-masked, randomized, vehicle-controlled dose-response study assessing the safety and ocular hypotensive efficacy of VVN539 in subjects with POAG or OHT. Three different dosing regimens (once a day [q.d.] in the morning, q.d. in the evening and twice a day [b.i.d.]) will be tested for 7-9 days, each.
- Conditions
- Glaucoma, Open-Angle
- Being tested
- VVN539 Ophthalmic Solution 0.02%, VVN539 Ophthalmic Solution 0.04%, VVN539 Ophthalmic Solution Vehicle
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VVN539 Ophthalmic Solution 0.02%Drug
Once a day [q.d.] in the morning, q.d. in the evening and twice a day [b.i.d.]) will be tested for 7-9 days
VVN539 Ophthalmic Solution 0.04%Drug
Once a day [q.d.] in the morning, q.d. in the evening and twice a day [b.i.d.]) will be tested for 7-9 days
VVN539 Ophthalmic Solution VehicleDrug
Once a day [q.d.] in the morning, q.d. in the evening and twice a day [b.i.d.]) will be tested for 7-9 days
| Study group | Role | What they receive |
|---|---|---|
| VVN539 Ophthalmic Solution 0.02% | Active comparator | VVN539 Ophthalmic Solution 0.02% Receives: Drug: VVN539 Ophthalmic Solution 0.02% |
| VVN539 Ophthalmic Solution 0.04% | Active comparator | VVN539 Ophthalmic Solution 0.04% Receives: Drug: VVN539 Ophthalmic Solution 0.04% |
| VVN539 Ophthalmic Solution Vehicle | Placebo comparator | VVN539 Ophthalmic Solution Vehicle Receives: Drug: VVN539 Ophthalmic Solution Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Intraocular Pressure
mmHg
Measured: 8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21
Secondary outcomes (1)
Mean Change in Intraocular Pressure From Baseline
mmHg
Measured: 8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start12 Jul 2022
- Primary completion22 Dec 2022
- Study completion22 Dec 2022
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.
- Other trials for Glaucoma, Open-AngleStudies 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, randomized, parallel
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- VivaVision Biotech, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiao-Yan Li, M.D., Study director, VivaVision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451329
- Sponsor's protocol ID
- VVN539-CS-201
- Status last verified
- Dec 2023
- First submitted
- 6 Jul 2022
- Last updated
- 17 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-masked, Randomized, Vehicle-controlled, Dose-response Study Assessing the Safety and Ocular Hypotensive Efficacy of VVN539 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT05451329
- Acronym / sponsor ID
- VVN539-CS-201
- Conditions
- Glaucoma, Open-Angle
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- VivaVision Biotech, IncIndustry (pharma, biotech, devices)
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 11 Jul 2022 (actual)
- Results
- Posted 17 Jan 2024
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 prospective, parallel-comparison, multi-center, double-masked, randomized, vehicle-controlled dose-response study assessing the safety and ocular hypotensive efficacy of VVN539 in subjects with POAG or OHT. Three different dosing regimens (once a day [q.d.] in the morning, q.d. in the evening and twice a day [b.i.d.]) will be tested for 7-9 days, each.
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, randomized, parallel
| Arm | Type | Receives |
|---|---|---|
| VVN539 Ophthalmic Solution 0.02% | Active comparator | Drug: VVN539 Ophthalmic Solution 0.02%VVN539 Ophthalmic Solution 0.02% |
| VVN539 Ophthalmic Solution 0.04% | Active comparator | Drug: VVN539 Ophthalmic Solution 0.04%VVN539 Ophthalmic Solution 0.04% |
| VVN539 Ophthalmic Solution Vehicle | Placebo comparator | Drug: VVN539 Ophthalmic Solution VehicleVVN539 Ophthalmic Solution Vehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older.
- Diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes that are untreated, or if treated, in the opinion of the investigator are well controlled on 2 or fewer ocular hypotensive medications prior to Visit 1.
- Unmedicated intraocular pressure of ≥ 22 mm Hg and ≤ 36 mm Hg in the study eye, with no more than 5 mm Hg inter-eye difference at 08:00AM and 10:00AM at Visit 2.
- Corrected visual acuity in each eye +1.0 or better by Early Treatment Diabetic Retinopathy Scale in each eye (equivalent to Snellen 20/200)
Key exclusion criteria (2 listed)
- Known hypersensitivity to any kinase inhibitors, any excipient or preservative of the formulation or to topical anesthetics or fluorescein.
- Unmedicated IOP of > 36 mm Hg in either eye at any time point at Visit 2.
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 |
|---|---|---|
| VVN539 Ophthalmic Solution 0.02%Once a day [q.d.] in the morning, q.d. in the evening and twice a day [b.i.d.]) will be tested for 7-9 days | Drug | VVN539 Ophthalmic Solution 0.02% |
| VVN539 Ophthalmic Solution 0.04%Once a day [q.d.] in the morning, q.d. in the evening and twice a day [b.i.d.]) will be tested for 7-9 days | Drug | VVN539 Ophthalmic Solution 0.04% |
| VVN539 Ophthalmic Solution VehicleOnce a day [q.d.] in the morning, q.d. in the evening and twice a day [b.i.d.]) will be tested for 7-9 days | Drug | VVN539 Ophthalmic Solution Vehicle |
Primary outcome
Mean Intraocular Pressure
Time frame: 8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21
mmHg
1 secondary outcome
Mean Change in Intraocular Pressure From Baseline
Time frame: 8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Xiao-Yan Li, M.D. study director
VivaVision
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 VVN539 Ophthalmic Solution 0.02% and VVN539 Ophthalmic Solution 0.04% in people with Glaucoma, Open-Angle, 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 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: finished, as of the sponsor's last update on 17 Jan 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 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 17 Jan 2024). 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?
Mean Intraocular Pressure (time frame: 8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21). 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 17 Jan 2024.