Intraocular PressureNCT04700189
A FIH Trial of the STREAMLINE™ SURGICAL SYSTEM
A study testing ab interno canaloplasty in people with Intraocular Pressure and Open Angle Glaucoma, run by New World Medical, Inc. at 1 site in Mexico.
Trial summary
The purpose of this study is to evaluate the safety and Intraocular pressure lowering effectiveness of the Streamline™ Surgical System. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Intraocular Pressure, Open Angle Glaucoma
- What is being tested?
- ab interno canaloplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteMexico
- Study dates
- 4 Dec 2020to 21 Sep 2022
- 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
- Subjects must meet all the following criteria in order to be eligible for participation in this study:
- Subjects qualifying for cataract surgery
- Subjects with diagnosis of open-angle glaucoma in at least one eye with unmedicated IOP of 21-36 mmHg.
Who cannot join
- Subjects are ineligible for participation in this study if s/he meets any of the following criteria:
- Patients who could not be washed-out of IOP-lowering medications. .
Trial locations and contacts
1 site in 1 country.
About this study
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
The purpose of this study is to evaluate the safety and Intraocular pressure lowering effectiveness of the Streamline™ Surgical System.
Read the detailed description
This is a prospective, nonrandomized, open-label study evaluating the safety and IOP-lowering effectiveness of CPI Visco-Surgical System (STREAMLINE™ SURGICAL SYSTEM) in patients with open-angle glaucoma undergoing cataract surgery.
- Conditions
- Intraocular Pressure, Open Angle Glaucoma
- Being tested
- ab interno canaloplasty
- Keywords
- Intraocular Pressure, Glaucoma, Glaucoma Surgery, Ab interno
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ab interno canaloplastyDevice
A modification of traditional canaloplasty procedure. Can be combined with or done without cataract surgery.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Streamline following cataract surgery | Experimental | Treatment with Streamline System following phacoemulsification Receives: Device: ab interno canaloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of unmedicated eyes with intraocular pressure (IOP) reduction of ≥20%
Descriptive
Measured: From Baseline at Month 12
Secondary outcomes (2)
Changes from baseline in intraocular pressure (IOP)
Exploratory analysis
Measured: From Baseline at Month 12
Changes from baseline in number of IOP lowering medications
Exploratory analysis
Measured: From Baseline at Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start4 Dec 2020
- Primary completion21 Sep 2022
- Study completion21 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular PressureStudies 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
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- New World Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gabriel Lozcano, MD, Principal investigator, Puebla, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700189
- Sponsor's protocol ID
- DF6-CL-20-03
- Status last verified
- May 2023
- First submitted
- 18 Dec 2020
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 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
- NCT04700189
- Acronym / sponsor ID
- DF6-CL-20-03
- Conditions
- Intraocular Pressure, Open Angle Glaucoma
- Keywords
- Intraocular Pressure, Glaucoma, Glaucoma Surgery, Ab interno
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- New World Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Dec 2020 (actual)
- Primary completion
- 21 Sep 2022 (actual)
- Study completion
- 21 Sep 2022 (actual)
- First posted
- 7 Jan 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.
The purpose of this study is to evaluate the safety and Intraocular pressure lowering effectiveness of the Streamline™ Surgical System.
Detailed description
This is a prospective, nonrandomized, open-label study evaluating the safety and IOP-lowering effectiveness of CPI Visco-Surgical System (STREAMLINE™ SURGICAL SYSTEM) in patients with open-angle glaucoma undergoing cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with Streamline following cataract surgery | Experimental | Device: ab interno canaloplastyTreatment with Streamline System following phacoemulsification |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects must meet all the following criteria in order to be eligible for participation in this study:
- Subjects qualifying for cataract surgery
- Subjects with diagnosis of open-angle glaucoma in at least one eye with unmedicated IOP of 21-36 mmHg.
Key exclusion criteria (2 listed)
- Subjects are ineligible for participation in this study if s/he meets any of the following criteria:
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 |
|---|---|---|
| ab interno canaloplastyA modification of traditional canaloplasty procedure. Can be combined with or done without cataract surgery. | Device | Treatment with Streamline following cataract surgery |
Primary outcome
Proportion of unmedicated eyes with intraocular pressure (IOP) reduction of ≥20%
Time frame: From Baseline at Month 12
Descriptive
2 secondary outcomes
Changes from baseline in intraocular pressure (IOP)
Time frame: From Baseline at Month 12
Changes from baseline in number of IOP lowering medications
Time frame: From Baseline at Month 12
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 11 May 2023.
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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.
Gabriel Lozcano, MD principal investigator
Puebla, Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ab interno canaloplasty in people with Intraocular Pressure and Open Angle Glaucoma, run by New World Medical, Inc. at 1 site in Mexico.
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 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 11 May 2023. 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 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 intraocular pressure (IOP) reduction of ≥20% (time frame: From Baseline at Month 12). 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 11 May 2023.