Ocular HypertensionPhase 1NCT01943721
A Study of the VISION5 Product in Patients With Glaucoma or Ocular Hypertension
A Phase 1 study testing VISION5 Product in people with Ocular Hypertension and Primary Open Angle Glaucoma, run by ForSight Vision5, Inc. at 1 site in Latvia.
Trial summary
The objective of this Phase 1 study is to evaluate the VISION5 Product's safety and efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Hypertension, Primary Open Angle Glaucoma
- What is being tested?
- VISION5 Product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteLatvia
- Study dates
- Oct 2013to Jun 2014
- Phase
- Phase 1
- 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
- Written informed consent
- Primary open-angle glaucoma or ocular hypertension in both eyes
- Best-corrected distance vision of 20/100 or better
- Stable visual field
Who cannot join
- Cup-to-disc ratio greater than 0.8
- Laser surgery for glaucoma/ocular hypertension on one or both eyes within the last 12 months
- Corneal refractive surgery within prior 6 months
- Past history of any incisional surgery for glaucoma at any time
- Corneal abnormalities that would interfere with tonometry readings
- Current participation in an investigational drug or device study or participation in such a study within 30 days of screening
Trial locations and contacts
1 site in 1 country.
Latvia1 site
Contact ForSight VISION5 for Trial Locations
Contact ForSight Vision5 For Trial Locations
About this study
The objective of this Phase 1 study is to evaluate the VISION5 Product's safety and efficacy.
- Conditions
- Ocular Hypertension, Primary Open Angle Glaucoma
- Being tested
- VISION5 Product
- Medical subject headings
- Ocular Hypertension, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VISION5 ProductDrug
| Study group | Role | What they receive |
|---|---|---|
| VISION5 Product | Experimental | VISION5 Product in both eyes Receives: Drug: VISION5 Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Tonometry (change from baseline)
Measured: Week 2, 6, 12 and Months 4,5,6
Secondary outcomes (1)
Safety as assessed by Slit Lamp Exam
Measured: Weeks 2,6,12 and Months 4,5,6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular HypertensionStudies 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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- ForSight Vision5, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne Rubin, Study director, ForSight VISION5
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943721
- Sponsor's protocol ID
- ForSight VISION5 Study 504
- Status last verified
- Dec 2014
- First submitted
- 10 Sep 2013
- Last updated
- 17 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the VISION5 Product in Patients With Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT01943721
- Acronym / sponsor ID
- ForSight VISION5 Study 504
- Conditions
- Ocular Hypertension, Primary Open Angle Glaucoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- ForSight Vision5, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 17 Sep 2013 (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.
The objective of this Phase 1 study is to evaluate the VISION5 Product's safety and efficacy.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VISION5 Product | Experimental | Drug: VISION5 ProductVISION5 Product in both eyes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent
- Primary open-angle glaucoma or ocular hypertension in both eyes
- Best-corrected distance vision of 20/100 or better
- Stable visual field
Key exclusion criteria (6 listed)
- Cup-to-disc ratio greater than 0.8
- Laser surgery for glaucoma/ocular hypertension on one or both eyes within the last 12 months
- Corneal refractive surgery within prior 6 months
- Past history of any incisional surgery for glaucoma at any time
- Corneal abnormalities that would interfere with tonometry readings
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 |
|---|---|---|
| VISION5 Product | Drug | VISION5 Product |
Primary outcome
Ocular Tonometry (change from baseline)
Time frame: Week 2, 6, 12 and Months 4,5,6
1 secondary outcome
Safety as assessed by Slit Lamp Exam
Time frame: Weeks 2,6,12 and Months 4,5,6
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 17 Dec 2014.
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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.
Anne Rubin study director
ForSight VISION5
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VISION5 Product in people with Ocular Hypertension and Primary Open Angle Glaucoma, run by ForSight Vision5, Inc. at 1 site in Latvia.
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 6 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 Dec 2014. 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 Latvia. 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 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.
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?
Ocular Tonometry (change from baseline) (time frame: Week 2, 6, 12 and Months 4,5,6). 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 Dec 2014.