- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02226094
Safety and Efficacy of Deep Wave Trabeculoplasty (DWT) in Primary Open Angle Glaucoma and Ocular Hypertension
April 3, 2017 updated by: OcuTherix, Inc.
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.
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Makati City, Philippines
- Asian Eye Institute
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Makati City, Philippines
- Pacific Eye and Laser Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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;
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: DWT device dose A
Deep Wave Trabeculoplasty (DWT) dose A (10 second spot treatments).
|
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.
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ACTIVE_COMPARATOR: Ellex Tango SLT machine
Selective Laser Trabeculoplasty (SLT)
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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.
|
SHAM_COMPARATOR: DWT Sham
Deep Wave Trabeculoplasty (DWT) but device not applied to ocular surface.
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Same as DWT device dose A except device not applied to ocular surface.
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EXPERIMENTAL: DWT device dose B
Deep Wave Trabeculoplasty (DWT) dose B (20 second spot treatments).
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Same as DWT device dose A except 20 second spot treatments.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percent decrease in IOP and change in dependence on IOP-lowering medications from baseline
Time Frame: 6 months
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6 months
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Intra-procedural and post-procedural adverse events
Time Frame: 6 months
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Harvey Siy Uy, MD, Pacific Eye and Laser Institute
- Principal Investigator: Edgar U. Leuenberger, MD, Asian Eye Institute
- Principal Investigator: Maria I Yap-Veloso, MD, Asian Eye Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (ACTUAL)
June 1, 2015
Study Completion (ACTUAL)
December 1, 2015
Study Registration Dates
First Submitted
August 20, 2014
First Submitted That Met QC Criteria
August 22, 2014
First Posted (ESTIMATE)
August 27, 2014
Study Record Updates
Last Update Posted (ACTUAL)
April 4, 2017
Last Update Submitted That Met QC Criteria
April 3, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DWT CIP 002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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