Primary Open Angle GlaucomaCOMPARENCT02023242
Comparing Effectiveness of the Hydrus Microstent (TM) to Two iStents to Lower IOP in Phakic Eyes
A study testing Hydrus Microstent and iStent Trabecular Micro Bypass in people with Primary Open Angle Glaucoma and Pseudoexfoliative Glaucoma, run by Ivantis, Inc. at 1 site in United States.
Trial summary
This clinical trial compares two implantable devices intended to lower the pressure inside the eye of glaucoma patients. Read more about this study
- Who is it for?
- Ages 45 to 84 years
- Conditions the study is for
- Primary Open Angle Glaucoma, Pseudoexfoliative Glaucoma, Pigmentary Glaucoma
- What is being tested?
- Hydrus Microstent and iStent Trabecular Micro Bypass
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Jan 2018
- Phase
- Interventional
- 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 45 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of primary open angle glaucoma (POAG), Pseudoexfoliative (PXG) glaucoma, or Pigmentary glaucoma (PG)
- A phakic lens with BCVA of 20/30 or better
Who cannot join
- Forms of primary or secondary glaucoma not listed above
- Prior glaucoma surgery in the study eye
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Richard Hope at Ivantis
Irvine, California, 92618
About this study
Official title: A Prospective, Multicenter, Randomized Comparison of the Hydrus to the iStent® for Lowering Intraocular Pressure in Primary Open Angle Glaucoma
This clinical trial compares two implantable devices intended to lower the pressure inside the eye of glaucoma patients.
Read the detailed description
This is a prospective, multicenter, single-masked, randomized clinical trial comparing the Hydrus Microstent to two iStent implants for the reduction of intraocular pressure in phakic patients with a positive diagnosis of primary open angle glaucoma, pseudoexfoliative glaucoma, or pigmentary dispersion glaucoma. Post-operative follow-up visits will be conducted at regular intervals.
- Being tested
- Hydrus Microstent, iStent Trabecular Micro Bypass
- Keywords
- Primary open angle glaucoma, POAG, Pseudoexfoliative glaucoma, PXG, Pigmentary glaucoma, PG, Hydrus
- 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.
Hydrus MicrostentDevice
Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.
iStent Trabecular Micro BypassDevice
Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.
| Study group | Role | What they receive |
|---|---|---|
| Hydrus Microstent | Experimental | Patients randomized to the Hydrus Microstent . Receives: Device: Hydrus Microstent |
| iStent Trabecular Micro Bypass | Active comparator | Patients randomized to the iStent Trabecular Micro Bypass Receives: Device: iStent Trabecular Micro Bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unmedicated IOP </= 19 mmHg at 12 Months
Percentage of subjects with IOP </= 19 mmHg and without the use of ocular hypotensive medications at 12 months
Measured: 12 months
Secondary outcomes (4)
The Percentage of Subjects Who Are Not Using Ocular Hypotensive Medications at 12 and 24 Months
The percentage of subjects who are not using ocular hypotensive medications at 12 and 24 months
Measured: 12 & 24 Months
Mean Medication Use at 12 and 24 Months
The mean medication use at 12 and 24 months
Measured: 12 & 24 Months
Unmedicated IOP </= 19 mmHg at 24 Months
Percentage of subjects with IOP </= 19 mmHg and without the use of ocular hypotensive medications at 24 months
Measured: 24 Months
Unmedicated IOP </= 18 mmHg at 12 Months
Percentage of subjects with IOP </= 18 mmHg and without the use of ocular hypotensive medications at 12 months
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 posted30 Dec 2013 (estimated)
- Study startOct 2012
- Primary completionAug 2017
- Study completionJan 2018
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 Primary 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ivantis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julian Garcia Feijoo, Prof. Med., Principal investigator, Madrid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02023242
- Sponsor's protocol ID
- CP-12-001
- Acronym
- COMPARE
- Status last verified
- Nov 2019
- First submitted
- 23 Dec 2013
- Last updated
- 10 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Comparison of the Hydrus to the iStent® for Lowering Intraocular Pressure in Primary Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT02023242
- Acronym / sponsor ID
- COMPARE / CP-12-001
- Keywords
- Primary open angle glaucoma, POAG, Pseudoexfoliative glaucoma, PXG, Pigmentary glaucoma, PG, Hydrus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Ivantis, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Aug 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 30 Dec 2013 (estimated)
- Results
- Posted 10 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial compares two implantable devices intended to lower the pressure inside the eye of glaucoma patients.
Detailed description
This is a prospective, multicenter, single-masked, randomized clinical trial comparing the Hydrus Microstent to two iStent implants for the reduction of intraocular pressure in phakic patients with a positive diagnosis of primary open angle glaucoma, pseudoexfoliative glaucoma, or pigmentary dispersion glaucoma. Post-operative follow-up visits will be conducted at regular intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrus Microstent | Experimental | Device: Hydrus MicrostentPatients randomized to the Hydrus Microstent . |
| iStent Trabecular Micro Bypass | Active comparator | Device: iStent Trabecular Micro BypassPatients randomized to the iStent Trabecular Micro Bypass |
Who may qualify
- Ages
- 45 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A diagnosis of primary open angle glaucoma (POAG), Pseudoexfoliative (PXG) glaucoma, or Pigmentary glaucoma (PG)
- A phakic lens with BCVA of 20/30 or better
Key exclusion criteria (2 listed)
- Forms of primary or secondary glaucoma not listed above
- Prior glaucoma surgery in the study eye
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 |
|---|---|---|
| Hydrus MicrostentDevice inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber. | Device | Hydrus Microstent |
| iStent Trabecular Micro BypassDevice inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber. | Device | iStent Trabecular Micro Bypass |
Primary outcome
Unmedicated IOP </= 19 mmHg at 12 Months
Time frame: 12 months
Percentage of subjects with IOP </= 19 mmHg and without the use of ocular hypotensive medications at 12 months
4 secondary outcomes
The Percentage of Subjects Who Are Not Using Ocular Hypotensive Medications at 12 and 24 Months
Time frame: 12 & 24 Months
Mean Medication Use at 12 and 24 Months
Time frame: 12 & 24 Months
Unmedicated IOP </= 19 mmHg at 24 Months
Time frame: 24 Months
Unmedicated IOP </= 18 mmHg at 12 Months
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Julian Garcia Feijoo, Prof. Med. principal investigator
Madrid, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrus Microstent and iStent Trabecular Micro Bypass in people with Primary Open Angle Glaucoma and Pseudoexfoliative Glaucoma, run by Ivantis, 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 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 10 Dec 2019. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2019). 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?
Unmedicated IOP </= 19 mmHg at 12 Months (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 10 Dec 2019.