Open Angle GlaucomaPhase 1/2NCT02129673
A Phase 1/2 Multicenter, Randomized, Study to Evaluate the Safety and Efficacy of VS101 Subconjunctival Latanoprost Insert in Subjects With Open-Angle Glaucoma or Ocular Hypertension
A Phase 1/2 study testing VS101 Insert Dose A, VS101 Insert Dose B and VS101 Insert Dose C in people with Open Angle Glaucoma and Ocular Hypertension, run by ViSci Ltd. at 1 site in United States.
Trial summary
Slow release formulation of latanoprost is compared for safety and pressure-lowering efficacy with topically administration of commercially available latanoprost in patient with glaucoma and ocular hypertension Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- VS101 Insert Dose A, VS101 Insert Dose B and VS101 Insert Dose C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Aug 2017
- Phase
- Phase 1/2
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18
- Open angle glaucoma or Ocular Hypertension
Who cannot join
- uncontrolled medical conditions
- wearing of contact lenses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1/2 Multicenter, Randomized, Controlled Dose-Finding Study to Evaluate the Safety and Ocular Hypotensive Efficacy of 3 Dose Levels of the VS101 Subconjunctival Latanoprost Insert for 3 Months in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Slow release formulation of latanoprost is compared for safety and pressure-lowering efficacy with topically administration of commercially available latanoprost in patient with glaucoma and ocular hypertension
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Being tested
- VS101 Insert Dose A, VS101 Insert Dose B, VS101 Insert Dose C, Latanoprost 0.005% eye drops
- Keywords
- Glaucoma, Intra-ocular pressure, Slow Release, Controlled release
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VS101 Insert Dose ADrug
Sustained release of latanoprost into the eye
VS101 Insert Dose BDrug
Sustained release of latanoprost into the eye
VS101 Insert Dose CDrug
Sustained release of latanoprost into the eye
Latanoprost 0.005% eye dropsDrug
Latanoprost 0.005% eye drops administered once daily on the eye
| Study group | Role | What they receive |
|---|---|---|
| VS101 Insert Dose A | Experimental | VS101 Insert Dose A placed under the conjunctiva Receives: Drug: VS101 Insert Dose A |
| VS101 Insert Dose B | Experimental | VS101 Insert Dose B placed under the conjunctiva Receives: Drug: VS101 Insert Dose B |
| VS101 Insert Dose C | Experimental | VS101 Insert Dose C placed under the conjunctiva Receives: Drug: VS101 Insert Dose C |
| Latanoprost 0.005% eye drops | Active comparator | Latanoprost 0.005% eye drops administered once daily on the eye Receives: Drug: Latanoprost 0.005% eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-ocular pressure
Measured: 12 weeks
Secondary outcomes (2)
Intra-ocular pressure
Measured: Week 8
Intra-ocular pressure
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle GlaucomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViSci Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129673
- Sponsor's protocol ID
- VS101-CS201
- Status last verified
- Oct 2017
- First submitted
- 30 Apr 2014
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Multicenter, Randomized, Controlled Dose-Finding Study to Evaluate the Safety and Ocular Hypotensive Efficacy of 3 Dose Levels of the VS101 Subconjunctival Latanoprost Insert for 3 Months in Subjects With Open-Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT02129673
- Acronym / sponsor ID
- VS101-CS201
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Keywords
- Glaucoma, Intra-ocular pressure, Slow Release, Controlled release
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- ViSci Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- May 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 2 May 2014 (estimated)
- 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.
Slow release formulation of latanoprost is compared for safety and pressure-lowering efficacy with topically administration of commercially available latanoprost in patient with glaucoma and ocular hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VS101 Insert Dose A | Experimental | Drug: VS101 Insert Dose AVS101 Insert Dose A placed under the conjunctiva |
| VS101 Insert Dose B | Experimental | Drug: VS101 Insert Dose BVS101 Insert Dose B placed under the conjunctiva |
| VS101 Insert Dose C | Experimental | Drug: VS101 Insert Dose CVS101 Insert Dose C placed under the conjunctiva |
| Latanoprost 0.005% eye drops | Active comparator | Drug: Latanoprost 0.005% eye dropsLatanoprost 0.005% eye drops administered once daily on the eye |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18
- Open angle glaucoma or Ocular Hypertension
Key exclusion criteria (2 listed)
- uncontrolled medical conditions
- wearing of contact lenses
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 |
|---|---|---|
| VS101 Insert Dose ASustained release of latanoprost into the eye | Drug | VS101 Insert Dose A |
| VS101 Insert Dose BSustained release of latanoprost into the eye | Drug | VS101 Insert Dose B |
| VS101 Insert Dose CSustained release of latanoprost into the eye | Drug | VS101 Insert Dose C |
| Latanoprost 0.005% eye dropsLatanoprost 0.005% eye drops administered once daily on the eye | Drug | Latanoprost 0.005% eye drops |
Primary outcome
Intra-ocular pressure
Time frame: 12 weeks
2 secondary outcomes
Intra-ocular pressure
Time frame: Week 8
Intra-ocular pressure
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
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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 1/2 study testing VS101 Insert Dose A, VS101 Insert Dose B and VS101 Insert Dose C in people with Open Angle Glaucoma and Ocular Hypertension, run by ViSci 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 2 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 14 Mar 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intra-ocular pressure (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 14 Mar 2018; AzTrials last refreshed its copy on 30 Oct 2026.