Back to results

Safety and Efficacy of Deep Wave Trabeculoplasty (DWT) in Primary Open Angle Glaucoma and Ocular Hypertension

Primary Purpose

Primary Open-angle Glaucoma (POAG), Ocular Hypertension (OHT)

Status

Terminated

Phase

Phase 1

Locations

Philippines

Study Type

Interventional

Intervention

DWT device dose A

Ellex Tango SLT machine

DWT device dose B

DWT sham

About this trial

This is an interventional treatment trial for Primary Open-angle Glaucoma (POAG) focused on measuring intra-ocular pressure, primary open-angle glaucoma, intra ocular pressure, primary open angle glaucoma, glaucoma, deep wave trabeculoplasty, ocular hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:
1. Optic disc or retinal nerve fiber layer structural abnormalities (substantiated by OCT); and/or
2. 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:
1. Greater than or equal to 18mmHg at the Screening Visit or have documented history of IOP being greater than or equal to 22mmHg;
2. 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

Sites / Locations

Asian Eye Institute
Pacific Eye and Laser Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Sham Comparator

Experimental

Arm Label

DWT device dose A

Ellex Tango SLT machine

DWT Sham

DWT device dose B

Arm Description

Deep Wave Trabeculoplasty (DWT) dose A (10 second spot treatments).

Selective Laser Trabeculoplasty (SLT)

Deep Wave Trabeculoplasty (DWT) but device not applied to ocular surface.

Deep Wave Trabeculoplasty (DWT) dose B (20 second spot treatments).

Outcomes

Primary Outcome Measures

Percent decrease in IOP and change in dependence on IOP-lowering medications from baseline

Intra-procedural and post-procedural adverse events

Secondary Outcome Measures

Full Information

NCT ID

NCT02226094

First Posted

August 20, 2014

Last Updated

April 3, 2017

Sponsor

OcuTherix, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02226094

Brief Title

Safety and Efficacy of Deep Wave Trabeculoplasty (DWT) in Primary Open Angle Glaucoma and Ocular Hypertension

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Terminated

Why Stopped

Lack of funding

Study Start Date

November 2013 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

OcuTherix, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Open-angle Glaucoma (POAG), Ocular Hypertension (OHT)

Keywords

intra-ocular pressure, primary open-angle glaucoma, intra ocular pressure, primary open angle glaucoma, glaucoma, deep wave trabeculoplasty, ocular hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DWT device dose A

Arm Type

Experimental

Arm Description

Deep Wave Trabeculoplasty (DWT) dose A (10 second spot treatments).

Arm Title

Ellex Tango SLT machine

Arm Type

Active Comparator

Arm Description

Selective Laser Trabeculoplasty (SLT)

Arm Title

DWT Sham

Arm Type

Sham Comparator

Arm Description

Deep Wave Trabeculoplasty (DWT) but device not applied to ocular surface.

Arm Title

DWT device dose B

Arm Type

Experimental

Arm Description

Deep Wave Trabeculoplasty (DWT) dose B (20 second spot treatments).

Intervention Type

Device

Intervention Name(s)

DWT device dose A

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Ellex Tango SLT machine

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

DWT device dose B

Intervention Description

Same as DWT device dose A except 20 second spot treatments.

Intervention Type

Device

Intervention Name(s)

DWT sham

Intervention Description

Same as DWT device dose A except device not applied to ocular surface.

Primary Outcome Measure Information:

Title

Percent decrease in IOP and change in dependence on IOP-lowering medications from baseline

Time Frame

6 months

Title

Intra-procedural and post-procedural adverse events

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Harvey Siy Uy, MD

Organizational Affiliation

Pacific Eye and Laser Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Edgar U. Leuenberger, MD

Organizational Affiliation

Asian Eye Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Maria I Yap-Veloso, MD

Organizational Affiliation

Asian Eye Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Asian Eye Institute

City

Makati City

Country

Philippines

Facility Name

Pacific Eye and Laser Institute

City

Makati City

Country

Philippines

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of Deep Wave Trabeculoplasty (DWT) in Primary Open Angle Glaucoma and Ocular Hypertension

We'll reach out to this number within 24 hrs