Primary Open-angle Glaucoma (POAG)Phase 1/2NCT02226094
Safety and Efficacy of Deep Wave Trabeculoplasty (DWT) in Primary Open Angle Glaucoma and Ocular Hypertension
A Phase 1/2 study testing DWT device dose A, Ellex Tango SLT machine and DWT device dose B in people with Primary Open-angle Glaucoma (POAG) and Ocular Hypertension (OHT), run by OcuTherix, Inc. at 2 sites in Philippines.
Trial summary
The primary purpose of this study is to investigate the safety and efficacy of bilateral DWT in subjects with POAG or OHT compared to active and sham controls. The secondary purpose of the study is to investigate the durability, repeatability, and does response of the same. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Open-angle Glaucoma (POAG), Ocular Hypertension (OHT)
- What is being tested?
- DWT device dose A, Ellex Tango SLT machine and DWT device dose B
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 2 sitesPhilippines
- Study dates
- Nov 2013to Dec 2015
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, 18 years or older.
- Subjects diagnosed with either POAG or OHT in both eyes. The diagnosis of POAG must include evidence of:
- Optic disc or retinal nerve fiber layer structural abnormalities (substantiated by OCT); and/or
- Visual field abnormality (substantiated with the Humphrey automated perimeter using the SITA Standard 24-2 testing algorithm. Mean deviation (MD) score must be -15dB < MD < 0dB.
- Subjects with a 9:00AM (+/- 1 hour) median IOP in both eyes that is:
- Greater than or equal to 18mmHg at the Screening Visit or have documented history of IOP being greater than or equal to 22mmHg;
Show all 10Show fewer
- Greater than or equal to 22mmHg at both Eligibility Visits.
- Subjects currently using one or more topical medications to control their IOP.
- Subjects able and willing to comply with the protocol, including randomization assignment and all follow-up visits.
- Subjects that sign the informed consent form.
Who cannot join
- Subjects who are pregnant, lactating, or planning to become pregnant during the course of the study.
- Subjects with any form of glaucoma other than primary open-angle glaucoma (e.g., pseudo exfoliation or pigmentary glaucoma).
- Other exclusion criteria apply
Trial locations and contacts
2 sites in 1 country.
Philippines2 sites
Asian Eye Institute
Makati City
Pacific Eye and Laser Institute
Makati City
About this study
Official title: A Prospective, Randomized, Controlled Clinical Feasibility Investigation of the Safety and Efficacy of Deep Wave Trabeculoplasty (DWT) in Primary Open Angle Glaucoma (POAG) and Ocular Hypertension (OHT) Subjects
The primary purpose of this study is to investigate the safety and efficacy of bilateral DWT in subjects with POAG or OHT compared to active and sham controls. The secondary purpose of the study is to investigate the durability, repeatability, and does response of the same.
- Being tested
- DWT device dose A, Ellex Tango SLT machine, DWT device dose B, DWT sham
- Keywords
- intra-ocular pressure, primary open-angle glaucoma, intra ocular pressure, primary open angle glaucoma, glaucoma, deep wave trabeculoplasty, ocular hypertension
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWT device dose ADevice
Deep Wave Trabeculoplasty (DWT) is an investigational device intended to reduce IOP in patients with POAG or OHT. The DWT device applies focal mechanical oscillation (low amplitude, sonic frequency) to the surface of the eye proximate the limbal region and anterior to the trabecular meshwork (TM). Mechanical oscillation of the TM by the DWT device is believed to initiate a physiological cascade to restore function of the TM, increase the outflow of aqueous humor and thereby decrease the IOP. DWT involves 24 spot treatments applied around the limbal region on the ocular surface. Dose A refers to 10 second spot treatments.
Ellex Tango SLT machineDevice
Laser trabeculoplasty is the application of a laser beam to burn areas of the trabecular meshwork, located near the base of the iris, to increase fluid outflow. Selective laser trabeculoplasty (SLT) uses a Nd:YAG laser to target specific cells within the trabecular meshwork and create thermal damage.
DWT device dose BDevice
Same as DWT device dose A except 20 second spot treatments.
DWT shamDevice
Same as DWT device dose A except device not applied to ocular surface.
| Study group | Role | What they receive |
|---|---|---|
| DWT device dose A | Experimental | Deep Wave Trabeculoplasty (DWT) dose A (10 second spot treatments). Receives: Device: DWT device dose A |
| Ellex Tango SLT machine | Active comparator | Selective Laser Trabeculoplasty (SLT) Receives: Device: Ellex Tango SLT machine |
| DWT Sham | Sham comparator | Deep Wave Trabeculoplasty (DWT) but device not applied to ocular surface. Receives: Device: DWT sham |
| DWT device dose B | Experimental | Deep Wave Trabeculoplasty (DWT) dose B (20 second spot treatments). Receives: Device: DWT device dose B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent decrease in IOP and change in dependence on IOP-lowering medications from baseline
Measured: 6 months
Intra-procedural and post-procedural adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startNov 2013
- Primary completionJun 2015
- Study completionDec 2015
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open-angle Glaucoma (POAG)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- OcuTherix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Harvey Siy Uy, MD, Principal investigator, Pacific Eye and Laser InstituteEdgar U. Leuenberger, MD, Principal investigator, Asian Eye InstituteMaria I Yap-Veloso, MD, Principal investigator, Asian Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226094
- Sponsor's protocol ID
- DWT CIP 002
- Status last verified
- Apr 2017
- First submitted
- 20 Aug 2014
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Clinical Feasibility Investigation of the Safety and Efficacy of Deep Wave Trabeculoplasty (DWT) in Primary Open Angle Glaucoma (POAG) and Ocular Hypertension (OHT) Subjects
- ClinicalTrials.gov ID
- NCT02226094
- Acronym / sponsor ID
- DWT CIP 002
- Keywords
- intra-ocular pressure, primary open-angle glaucoma, intra ocular pressure, primary open angle glaucoma, glaucoma, deep wave trabeculoplasty, ocular hypertension
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 35 participants (actual)
- Lead sponsor
- OcuTherix, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 Aug 2014 (estimated)
- 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 primary purpose of this study is to investigate the safety and efficacy of bilateral DWT in subjects with POAG or OHT compared to active and sham controls. The secondary purpose of the study is to investigate the durability, repeatability, and does response of the same.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DWT device dose A | Experimental | Device: DWT device dose ADeep Wave Trabeculoplasty (DWT) dose A (10 second spot treatments). |
| Ellex Tango SLT machine | Active comparator | Device: Ellex Tango SLT machineSelective Laser Trabeculoplasty (SLT) |
| DWT Sham | Sham comparator | Device: DWT shamDeep Wave Trabeculoplasty (DWT) but device not applied to ocular surface. |
| DWT device dose B | Experimental | Device: DWT device dose BDeep Wave Trabeculoplasty (DWT) dose B (20 second spot treatments). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female subjects, 18 years or older.
- Subjects diagnosed with either POAG or OHT in both eyes. The diagnosis of POAG must include evidence of:
- Subjects with a 9:00AM (+/- 1 hour) median IOP in both eyes that is:
- Subjects currently using one or more topical medications to control their IOP.
- Subjects able and willing to comply with the protocol, including randomization assignment and all follow-up visits.
Key exclusion criteria (3 listed)
- Subjects who are pregnant, lactating, or planning to become pregnant during the course of the study.
- Subjects with any form of glaucoma other than primary open-angle glaucoma (e.g., pseudo exfoliation or pigmentary glaucoma).
- Other exclusion criteria apply
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 |
|---|---|---|
| DWT device dose ADeep Wave Trabeculoplasty (DWT) is an investigational device intended to reduce IOP in patients with POAG or OHT. The DWT device applies focal mechanical oscillation (low amplitude, sonic frequency) to the surface of the eye proximate the limbal region and anterior to the trabecular meshwork (TM). Mechanical oscillation of the TM by the DWT device is believed to initiate a physiological cascade to restore function of the TM, increase the outflow of aqueous humor and thereby decrease the IOP. DWT involves 24 spot treatments applied around the limbal region on the ocular surface. Dose A refers to 10 second spot treatments. | Device | DWT device dose A |
| Ellex Tango SLT machineLaser trabeculoplasty is the application of a laser beam to burn areas of the trabecular meshwork, located near the base of the iris, to increase fluid outflow. Selective laser trabeculoplasty (SLT) uses a Nd:YAG laser to target specific cells within the trabecular meshwork and create thermal damage. | Device | Ellex Tango SLT machine |
| DWT device dose BSame as DWT device dose A except 20 second spot treatments. | Device | DWT device dose B |
| DWT shamSame as DWT device dose A except device not applied to ocular surface. | Device | DWT Sham |
Primary outcome
Percent decrease in IOP and change in dependence on IOP-lowering medications from baseline
Time frame: 6 months
Intra-procedural and post-procedural adverse events
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
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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.
Harvey Siy Uy, MD principal investigator
Pacific Eye and Laser Institute
Edgar U. Leuenberger, MD principal investigator
Asian Eye Institute
Maria I Yap-Veloso, MD principal investigator
Asian Eye Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DWT device dose A, Ellex Tango SLT machine and DWT device dose B in people with Primary Open-angle Glaucoma (POAG) and Ocular Hypertension (OHT), run by OcuTherix, Inc. at 2 sites in Philippines.
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 10 inclusion and 3 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: stopped early, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Philippines. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of funding). 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?
Percent decrease in IOP and change in dependence on IOP-lowering medications from baseline (time frame: 6 months). The study lists 2 primary outcomes in all. 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 4 Apr 2017.