GlaucomaNCT05127551
Clinical Study of Glaukos® Trabecular Micro-Bypass System Model iS3 Infinite Vs. Competitor
A study testing iStent Infinite and Competitor Device in people with Glaucoma and Glaucoma, Open-Angle, run by Glaukos Corporation at 1 site in Canada.
Trial summary
A study of the iStent Infinite product in the treatment of open-angle glaucoma vs competitor Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Glaucoma, Glaucoma, Open-Angle
- What is being tested?
- iStent Infinite and Competitor Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 siteCanada
- Study dates
- 27 Nov 2021to 28 Feb 2025
- Phase
- Interventional
- 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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Primary Open-Angle Glaucoma (POAG) or Secondary Pseudoexfoliative Glacoma (PEXG) or Secondary Pigmentary Glaucoma (PG)
Who cannot join
- Any other type of glaucoma including, but not limited to: traumatic glaucoma, angle recession glaucoma, uveitic glaucoma, neovascular glaucoma, angle closure glaucoma (ACG) and glaucoma associated with vascular disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Controlled, Comparitive Multicenter Clinical Study of Glaukos® Trabecular Micro-Bypass System Model iS3 Infinite® vs Competitor in Adult Subjects With Primary Open-Angle Glaucoma (POAG)
A study of the iStent Infinite product in the treatment of open-angle glaucoma vs competitor
- Conditions
- Glaucoma, Glaucoma, Open-Angle
- Being tested
- iStent Infinite, Competitor Device
- Keywords
- Glaucoma, MIGS
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iStent InfiniteDevice
Implantation of the iStent Infinite
Competitor DeviceDevice
Implantation of competitor device
| Study group | Role | What they receive |
|---|---|---|
| iStent Infinite | Active comparator | Subjects implanted with iStent Infinite system Receives: Device: iStent Infinite |
| Competitor Device | Active comparator | Subject implanted with competitor device Receives: Device: Competitor Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Diurnal Intraocular Pressure
Change in Mean Diurnal Intraocular Pressure from Baseline over time
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start27 Nov 2021
- Primary completion29 Feb 2024
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glaukos Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127551
- Sponsor's protocol ID
- INFI-103-COMP
- Status last verified
- Aug 2024
- First submitted
- 9 Nov 2021
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Ahmed IIK, Berdahl JP, Yadgarov A, Reiss GR, Sarkisian SR Jr, Gagne S, Robles M, Voskanyan LA, Sadruddin O, Parizadeh D, Giamporcaro JE, Kothe AC, Katz LJ, Navratil T. Six-Month Outcomes from a Prospective, Randomized Study of iStent infinite Versus Hydrus in Open-Angle Glaucoma: The INTEGRITY Study. Ophthalmol Ther. 2025 May;14(5):1005-1024. doi: 10.1007/s40123-025-01126-x. Epub 2025 Mar 25.
PubMed 40128494
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Comparitive Multicenter Clinical Study of Glaukos® Trabecular Micro-Bypass System Model iS3 Infinite® vs Competitor in Adult Subjects With Primary Open-Angle Glaucoma (POAG)
- ClinicalTrials.gov ID
- NCT05127551
- Acronym / sponsor ID
- INFI-103-COMP
- Conditions
- Glaucoma, Glaucoma, Open-Angle
- Keywords
- Glaucoma, MIGS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2021 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 19 Nov 2021 (actual)
- 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.
A study of the iStent Infinite product in the treatment of open-angle glaucoma vs competitor
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iStent Infinite | Active comparator | Device: iStent InfiniteSubjects implanted with iStent Infinite system |
| Competitor Device | Active comparator | Device: Competitor DeviceSubject implanted with competitor device |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of Primary Open-Angle Glaucoma (POAG) or Secondary Pseudoexfoliative Glacoma (PEXG) or Secondary Pigmentary Glaucoma (PG)
Key exclusion criteria (1 listed)
- Any other type of glaucoma including, but not limited to: traumatic glaucoma, angle recession glaucoma, uveitic glaucoma, neovascular glaucoma, angle closure glaucoma (ACG) and glaucoma associated with vascular disorders
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 InfiniteImplantation of the iStent Infinite | Device | iStent Infinite |
| Competitor DeviceImplantation of competitor device | Device | Competitor Device |
Primary outcome
Change in Mean Diurnal Intraocular Pressure
Time frame: Month 24
Change in Mean Diurnal Intraocular Pressure from Baseline over time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Derived from this study: PubMed 40128494Ahmed IIK, Berdahl JP, Yadgarov A, Reiss GR, Sarkisian SR Jr, Gagne S, Robles M, Voskanyan LA, Sadruddin O, Parizadeh D, Giamporcaro JE, Kothe AC, Katz LJ, Navratil T. Six-Month Outcomes from a Prospective, Randomized Study of iStent infinite Versus Hydrus in Open-Angle Glaucoma: The INTEGRITY Study. Ophthalmol Ther. 2025 May;14(5):1005-1024. doi: 10.1007/s40123-025-01126-x. Epub 2025 Mar 25.
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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 study testing iStent Infinite and Competitor Device in people with Glaucoma and Glaucoma, Open-Angle, run by Glaukos Corporation at 1 site in Canada.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Aug 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 Canada. 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.
Are results available for this study?
Results are not available in the source record.
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?
Change in Mean Diurnal Intraocular Pressure (time frame: Month 24). 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 NCT05127551, 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 15 Aug 2024.