Subject With Primary Open-angle Glaucoma (POAG)Phase 4NCT01252914
A Prospective Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications Treated With One Suprachoroidal Stent
A Phase 4 study testing iStent Supra Stent in people with Subject With Primary Open-angle Glaucoma (POAG), run by Glaukos Corporation at 1 site in Armenia.
Trial summary
The purpose of this study is to assess the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Subject With Primary Open-angle Glaucoma (POAG)
- What is being tested?
- iStent Supra Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteArmenia
- Study dates
- Dec 2010to 16 Dec 2019
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with primary open-angle glaucoma (POAG)
- Subjects on two topical hypotensive medications
Who cannot join
- Traumatic, uveitic, neovascular, or angle closure glaucoma
- Fellow eye already enrolled
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With One Suprachoroidal Stent
The purpose of this study is to assess the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma.
Read the detailed description
The study assesses the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma.
- Being tested
- iStent Supra Stent
- Keywords
- Open angle, Glaucoma, Surgery, Ocular Hypertension, Eye Diseases
- Medical subject headings
- Glaucoma, Ocular Hypertension, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iStent Supra StentDevice
Implantation of one iStent Supra Stent through a small temporal clear corneal incision
| Study group | Role | What they receive |
|---|---|---|
| One iStent Supra Stent and medication | Experimental | The study assesses the efficacy and safety of one iStent Supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma Receives: Device: iStent Supra Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean diurnal Intraocular Pressure reduction of greater than or equal to 20% at month 12 vs. baseline
Measured: 12 months
Secondary outcomes (1)
Mean diurnal Intraocular Pressure < 18 mmHg at month 12
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startDec 2010
- Primary completion16 Dec 2019
- Study completion16 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subject With Primary Open-angle Glaucoma (POAG)Studies of the same condition, open and under way.
- More trials run by Glaukos CorporationThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glaukos Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lilit Voskanyan, MD, Principal investigator, SV Malayan Ophthalmological Center, Yerevan, Armenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252914
- Sponsor's protocol ID
- GCF-019
- Status last verified
- Sep 2022
- First submitted
- 1 Dec 2010
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With One Suprachoroidal Stent
- ClinicalTrials.gov ID
- NCT01252914
- Acronym / sponsor ID
- GCF-019
- Keywords
- Open angle, Glaucoma, Surgery, Ocular Hypertension, Eye Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2010 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 16 Dec 2019 (actual)
- First posted
- 3 Dec 2010 (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 purpose of this study is to assess the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma.
Detailed description
The study assesses the efficacy and safety of one iStent supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One iStent Supra Stent and medication | Experimental | Device: iStent Supra StentThe study assesses the efficacy and safety of one iStent Supra stent in the reduction of intraocular pressure associated with primary open-angle glaucoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with primary open-angle glaucoma (POAG)
- Subjects on two topical hypotensive medications
Key exclusion criteria (2 listed)
- Traumatic, uveitic, neovascular, or angle closure glaucoma
- Fellow eye already enrolled
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 |
|---|---|---|
| iStent Supra StentImplantation of one iStent Supra Stent through a small temporal clear corneal incision | Device | One iStent Supra Stent and medication |
Primary outcome
Mean diurnal Intraocular Pressure reduction of greater than or equal to 20% at month 12 vs. baseline
Time frame: 12 months
1 secondary outcome
Mean diurnal Intraocular Pressure < 18 mmHg at month 12
Time frame: 12 months
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 7 Sep 2022.
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.
Lilit Voskanyan, MD principal investigator
SV Malayan Ophthalmological Center, Yerevan, Armenia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing iStent Supra Stent in people with Subject With Primary Open-angle Glaucoma (POAG), run by Glaukos Corporation at 1 site in Armenia.
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 7 Sep 2022. 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 Armenia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Mean diurnal Intraocular Pressure reduction of greater than or equal to 20% at month 12 vs. baseline (time frame: 12 months). 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 7 Sep 2022; AzTrials last refreshed its copy on 2 Nov 2026.