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

NCT ID: NCT02226094

Last Updated: 2017-04-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DWT device dose A

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

Group Type: EXPERIMENTAL

DWT device dose A

Intervention Type: DEVICE

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 machine

Selective Laser Trabeculoplasty (SLT)

Group Type: ACTIVE_COMPARATOR

Ellex Tango SLT machine

Intervention Type: DEVICE

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 Sham

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

Group Type: SHAM_COMPARATOR

DWT sham

Intervention Type: DEVICE

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

DWT device dose B

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

Group Type: EXPERIMENTAL

DWT device dose B

Intervention Type: DEVICE

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

Interventions

DWT device dose A

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

Ellex Tango SLT machine

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

DWT device dose B

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

Intervention Type: DEVICE

DWT sham

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

Intervention Type: DEVICE

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:

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OcuTherix, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harvey Siy Uy, MD

Role: PRINCIPAL_INVESTIGATOR

Pacific Eye and Laser Institute

Edgar U. Leuenberger, MD

Role: PRINCIPAL_INVESTIGATOR

Asian Eye Institute

Maria I Yap-Veloso, MD

Role: PRINCIPAL_INVESTIGATOR

Asian Eye Institute

Locations

Asian Eye Institute

Makati City, , Philippines

Pacific Eye and Laser Institute

Makati City, , Philippines

Countries

Philippines

Other Identifiers

DWT CIP 002

Identifier Type: -

Identifier Source: org_study_id