Open Angle GlaucomaNCT05089474
A First in Human Clinical Trial to Evaluate the Safety and Effectiveness of the STREAMLINE SURGICAL SYSTEM in Patients With Open-Angle Glaucoma
A study testing Streamline Surgical System in people with Open Angle Glaucoma, run by New World Medical, Inc. at 3 sites in 3 countries.
Trial summary
A prospective, nonrandomized, open label study to evaluate the safety and IOP lowering effectiveness of the Streamline Surgical System, in patients with mild-to-moderate open angle glaucoma undergoing cataract surgery. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- Streamline Surgical System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 8 Mar 2021to 20 Apr 2023
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and execute written informed consent
- Males or female subjects at least 22 years of age.
- Subjects qualifying for cataract surgery
- Subjects diagnosed with mild to moderate open-angle glaucoma in at least one eye currently treated with 1-3 topical IOP-lowering medications
- Subjects with diagnosis of open-angle glaucoma in at least one eye with an unmedicated IOP of 21-36 mmHg
Who cannot join
- Women of child-bearing potential
- Modified Shaffer angle grade < 2
- Patients with severe or advanced glaucoma
- Intraocular surgery within the last 6 months or laser surgery within the last 3 months
- BCVA worse than 20/80 in either eye
- Patients with a previous peripheral iridotomy.
- Ocular infection or inflammation within the last 6 months.
- Any medication that would be contraindicated for a glaucoma surgical procedure.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
A prospective, nonrandomized, open label study to evaluate the safety and IOP lowering effectiveness of the Streamline Surgical System, in patients with mild-to-moderate open angle glaucoma undergoing cataract surgery.
Read the detailed description
A prospective, nonrandomized, open label study to evaluate the safety and IOP lowering effectiveness of the Streamline Surgical System, a viscoelastic delivery device, in patients with mild-to-moderate open angle glaucoma undergoing cataract surgery. This is a 12 month study conducted outside the US. Approximately 60 subjects will be enrolled.
- Conditions
- Open Angle Glaucoma
- Being tested
- Streamline Surgical System
- Keywords
- Open Angle Glaucoma, IOP, 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.
Streamline Surgical SystemDevice
The Streamline System is a device that delivers viscoelastic into Schlemm's Canal.
| Study group | Role | What they receive |
|---|---|---|
| Streamline | Experimental | Streamline Surgical System Receives: Device: Streamline Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of unmedicated eyes with IOP reduction of > 20% from Baseline at Month 12.
Primary Endpoint
Measured: 12 months
Secondary outcomes (3)
Adverse Events
Assess intraoperative and post operative AEs
Measured: 12 months
Mean IOP change
Mean IOP change in unmedicated IOP from baseline to M12
Measured: 12 months
Number of topical glaucoma medications
Number of topical glaucoma medications used at screening compared to 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 posted22 Oct 2021
- Study start8 Mar 2021
- Primary completion20 Apr 2023
- Study completion20 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, non-randomized, open label
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- New World Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089474
- Sponsor's protocol ID
- DF6-CL-20-01
- Status last verified
- Jan 2023
- First submitted
- 13 Oct 2021
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First in Human Clinical Trial to Evaluate the Safety and Effectiveness of the STREAMLINE SURGICAL SYSTEM in Patients With Open-Angle Glaucoma
- ClinicalTrials.gov ID
- NCT05089474
- Acronym / sponsor ID
- DF6-CL-20-01
- Conditions
- Open Angle Glaucoma
- Keywords
- Open Angle Glaucoma, IOP, viscoelastic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- New World Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 22 Oct 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 prospective, nonrandomized, open label study to evaluate the safety and IOP lowering effectiveness of the Streamline Surgical System, in patients with mild-to-moderate open angle glaucoma undergoing cataract surgery.
Detailed description
A prospective, nonrandomized, open label study to evaluate the safety and IOP lowering effectiveness of the Streamline Surgical System, a viscoelastic delivery device, in patients with mild-to-moderate open angle glaucoma undergoing cataract surgery. This is a 12 month study conducted outside the US. Approximately 60 subjects will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, non-randomized, open label
| Arm | Type | Receives |
|---|---|---|
| Streamline | Experimental | Device: Streamline Surgical SystemStreamline Surgical System |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to understand and execute written informed consent
- Males or female subjects at least 22 years of age.
- Subjects qualifying for cataract surgery
- Subjects diagnosed with mild to moderate open-angle glaucoma in at least one eye currently treated with 1-3 topical IOP-lowering medications
- Subjects with diagnosis of open-angle glaucoma in at least one eye with an unmedicated IOP of 21-36 mmHg
Key exclusion criteria (8 listed)
- Women of child-bearing potential
- Modified Shaffer angle grade < 2
- Patients with severe or advanced glaucoma
- Intraocular surgery within the last 6 months or laser surgery within the last 3 months
- BCVA worse than 20/80 in either 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 |
|---|---|---|
| Streamline Surgical SystemThe Streamline System is a device that delivers viscoelastic into Schlemm's Canal. | Device | Streamline |
Primary outcome
proportion of unmedicated eyes with IOP reduction of > 20% from Baseline at Month 12.
Time frame: 12 months
Primary Endpoint
3 secondary outcomes
Adverse Events
Time frame: 12 months
Mean IOP change
Time frame: 12 months
Number of topical glaucoma medications
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 13 Oct 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Streamline Surgical System in people with Open Angle Glaucoma, run by New World Medical, Inc. at 3 sites in 3 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 5 inclusion and 8 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 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Costa Rica, Dominican Republic, Mexico. 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?
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?
proportion of unmedicated eyes with IOP reduction of > 20% from Baseline at Month 12. (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 13 Oct 2023.