Open Angle GlaucomaViscoPassNCT02448875
Clinical Evaluation of Visco-Assisted CyPass® Micro-Stent Implantation in Patients With Open Angle Glaucoma
A study testing CyPass Micro-Stent and Viscoelastic in people with Open Angle Glaucoma, run by Transcend Medical, Inc. at 6 sites in 4 countries.
Trial summary
The purpose of this study is to assess the safety and effectiveness of the use of visco-assisted CyPass® Micro-Stent implantation for the lowering of intraocular pressure (IOP) in subjects who have open angle glaucoma (OAG). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- CyPass Micro-Stent and Viscoelastic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 21 Jun 2013to 22 Jun 2017
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of open angle glaucoma;
- Unmedicated IOP between 21 - 36 mmHg, inclusive;
- Normal angle anatomy at site of intended CyPass Micro-Stent implantation.
Who cannot join
- Advanced glaucoma;
- Prior incisional glaucoma surgery;
- Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma;
- Clinically significant ocular pathology other than glaucoma.
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Germany3 sites
Transcend Medical Investigative Site
Lübeck
Transcend Medical Investigative Site
Mainz
Transcend Medical Investigative Site
Neubrandenburg
About this study
Official title: Randomized, Prospective Clinical Evaluation of the Safety and Effectiveness of Visco-Assisted CyPass® Implantation in Patients With Open Angle Glaucoma
The purpose of this study is to assess the safety and effectiveness of the use of visco-assisted CyPass® Micro-Stent implantation for the lowering of intraocular pressure (IOP) in subjects who have open angle glaucoma (OAG).
Read the detailed description
The study was conducted in 2 phases. Only one eye per subject was treated for each independent phase.
Dose Selection Phase (Cohort 1): Subjects were randomized in a 1:1:1 ratio and implanted with either a CyPass Micro-Stent with targeted delivery of 30 microliters (μl) ophthalmic 5 viscoelastic, a CyPass Micro-Stent with targeted delivery of 60 μl of ophthalmic viscoelastic, or a CyPass Micro-Stent without adjunct viscoelastic in the study eye.
Expansion Phase (Cohort 2): Subjects were randomized in a 1:1 ratio and implanted with either the CyPass Micro-Stent without adjunct viscoelastic or the CyPass Micro-Stent with 60 μl of ophthalmic viscoelastic (based on Dose Selection results). Subjects were randomized to treatment on the day of their surgical procedure. A total of 9 scheduled visits were planned including Screening (Day -45 to -2), Baseline (Day -15 to -1), Surgery (Day 0), 1 Day (Day 1), 1 Week (Day 5-9), 1 Month (Day 21-35), 3 Month (Day 70-98), 6 Month (Day 150-210), and 12 Month (Day 330-420) visits. The total expected duration of participation for each subject was up to 13 months.
- Conditions
- Open Angle Glaucoma
- Being tested
- CyPass Micro-Stent, Viscoelastic
- 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.
CyPass Micro-StentDevice
Also called Model 2FX
Small tube with a through-lumen designed to redirect aqueous fluid from the front to the back of the eye in order to reduce intraocular pressure. Designed to be permanently implanted in the eye.
ViscoelasticDevice
Healon 5 ophthalmic viscoelastic used to increase the size of the aqueous drainage area created by the CyPass Micro-Stent
| Study group | Role | What they receive |
|---|---|---|
| CyPass | Active comparator | CyPass Micro-Stent without adjunct viscoelastic implanted in the study eye Receives: Device: CyPass Micro-Stent |
| CyPass30 | Experimental | CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic Receives: Device: CyPass Micro-Stent; Device: Viscoelastic |
| CyPass60 | Experimental | CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic Receives: Device: CyPass Micro-Stent; Device: Viscoelastic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With ≥ 20% Decrease From Baseline to 12 Months Postoperative in IOP Without Use of Ocular Hypotensive Medication
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study.
Measured: Baseline (Day -1), Month 12 PostOperative
Secondary outcomes (4)
Percentage of Subjects With Device-related Ocular Adverse Events
A device related adverse event (AE) was any AE that was considered to be possibly, probably, or definitely related to the device in the opinion of the investigator. Reported categorically as intraoperative (start date on the date of surgery) and postoperative (start date after surgery). One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study.
Measured: Up to Month 12 PostOperative
Mean Change From Baseline to 12 Months Postoperative in Medicated IOP
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A higher negative change indicates improvement. One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study.
Measured: Baseline (Day -1), Month 12 PostOperative
Percentage of Eyes Using Ocular Hypotensive Medication at 12 Months
The use of ocular hypotensive medications was assessed in subjects with at least one IOP-lowering medication at 12 Months. One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study.
Measured: Month 12 PostOperative
Mean Change From Screening to 12 Months Postoperative in Number of Topical IOP-lowering Medications Used
The number of IOP lowering medications in subjects at 12 months was compared to medicated baseline. A higher negative change indicates improvement. One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study.
Measured: Screening (Day -2), Month 12 PostOperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study start21 Jun 2013
- Primary completion22 Jun 2017
- Study completion22 Jun 2017
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 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
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Transcend Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alcon Research, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448875
- Sponsor's protocol ID
- TMI-13-01
- Other IDs
- GLD122-P001
- Acronym
- ViscoPass
- Status last verified
- May 2019
- First submitted
- 12 May 2015
- Last updated
- 12 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Prospective Clinical Evaluation of the Safety and Effectiveness of Visco-Assisted CyPass® Implantation in Patients With Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT02448875
- Acronym / sponsor ID
- ViscoPass / TMI-13-01
- Conditions
- Open Angle Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Transcend Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Jun 2013 (actual)
- Primary completion
- 22 Jun 2017 (actual)
- Study completion
- 22 Jun 2017 (actual)
- First posted
- 20 May 2015 (estimated)
- Results
- Posted 30 May 2019
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 safety and effectiveness of the use of visco-assisted CyPass® Micro-Stent implantation for the lowering of intraocular pressure (IOP) in subjects who have open angle glaucoma (OAG).
Detailed description
The study was conducted in 2 phases. Only one eye per subject was treated for each independent phase.
Dose Selection Phase (Cohort 1): Subjects were randomized in a 1:1:1 ratio and implanted with either a CyPass Micro-Stent with targeted delivery of 30 microliters (μl) ophthalmic 5 viscoelastic, a CyPass Micro-Stent with targeted delivery of 60 μl of ophthalmic viscoelastic, or a CyPass Micro-Stent without adjunct viscoelastic in the study eye.
Expansion Phase (Cohort 2): Subjects were randomized in a 1:1 ratio and implanted with either the CyPass Micro-Stent without adjunct viscoelastic or the CyPass Micro-Stent with 60 μl of ophthalmic viscoelastic (based on Dose Selection results). Subjects were randomized to treatment on the day of their surgical procedure. A total of 9 scheduled visits were planned including Screening (Day -45 to -2), Baseline (Day -15 to -1), Surgery (Day 0), 1 Day (Day 1), 1 Week (Day 5-9), 1 Month (Day 21-35), 3 Month (Day 70-98), 6 Month (Day 150-210), and 12 Month (Day 330-420) visits. The total expected duration of participation for each subject was up to 13 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CyPass | Active comparator | Device: CyPass Micro-StentCyPass Micro-Stent without adjunct viscoelastic implanted in the study eye |
| CyPass30 | Experimental | Device: CyPass Micro-Stent, Device: ViscoelasticCyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic |
| CyPass60 | Experimental | Device: CyPass Micro-Stent, Device: ViscoelasticCyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of open angle glaucoma;
- Unmedicated IOP between 21 - 36 mmHg, inclusive;
- Normal angle anatomy at site of intended CyPass Micro-Stent implantation.
Key exclusion criteria (4 listed)
- Advanced glaucoma;
- Prior incisional glaucoma surgery;
- Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma;
- Clinically significant ocular pathology other than glaucoma.
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 |
|---|---|---|
| CyPass Micro-StentAlso: Model 2FXSmall tube with a through-lumen designed to redirect aqueous fluid from the front to the back of the eye in order to reduce intraocular pressure. Designed to be permanently implanted in the eye. | Device | CyPass, CyPass30, CyPass60 |
| ViscoelasticHealon 5 ophthalmic viscoelastic used to increase the size of the aqueous drainage area created by the CyPass Micro-Stent | Device | CyPass30, CyPass60 |
Primary outcome
Percentage of Subjects With ≥ 20% Decrease From Baseline to 12 Months Postoperative in IOP Without Use of Ocular Hypotensive Medication
Time frame: Baseline (Day -1), Month 12 PostOperative
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study.
4 secondary outcomes
Percentage of Subjects With Device-related Ocular Adverse Events
Time frame: Up to Month 12 PostOperative
Mean Change From Baseline to 12 Months Postoperative in Medicated IOP
Time frame: Baseline (Day -1), Month 12 PostOperative
Percentage of Eyes Using Ocular Hypotensive Medication at 12 Months
Time frame: Month 12 PostOperative
Mean Change From Screening to 12 Months Postoperative in Number of Topical IOP-lowering Medications Used
Time frame: Screening (Day -2), Month 12 PostOperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Alcon Research study director
Alcon Research
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CyPass Micro-Stent and Viscoelastic in people with Open Angle Glaucoma, run by Transcend Medical, Inc. at 6 sites in 4 countries.
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 3 inclusion and 4 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 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Panama, Poland, Spain. 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 30 May 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?
Percentage of Subjects With ≥ 20% Decrease From Baseline to 12 Months Postoperative in IOP Without Use of Ocular Hypotensive Medication (time frame: Baseline (Day -1), Month 12 PostOperative). 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 12 Jun 2019.