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

NCT02226094 | Terminated Phase 1

• 1 other identifier: DWT CIP 002
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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)

Keywords

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

Outcome Measures

Primary Outcomes (2)

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

  6 months

• Intra-procedural and post-procedural adverse events

  6 months

Study Arms (4)

DWT device dose A

EXPERIMENTAL

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

Device: DWT device dose A

Ellex Tango SLT machine

ACTIVE COMPARATOR

Selective Laser Trabeculoplasty (SLT)

Device: Ellex Tango SLT machine

DWT Sham

SHAM COMPARATOR

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

Device: DWT sham

DWT device dose B

EXPERIMENTAL

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

Device: DWT device dose B

Interventions

DWT device dose A 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.

DWT device dose A

Ellex Tango SLT machine 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.

Ellex Tango SLT machine

DWT device dose B DEVICE

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

DWT device dose B

DWT sham DEVICE

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

DWT Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• OcuTherix, Inc.: lead

Study Sites (2)

Asian Eye Institute

Makati City, Philippines

Location

Pacific Eye and Laser Institute

Makati City, Philippines

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Glaucoma

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2014
• First Posted: August 27, 2014
• Study Start: November 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 4, 2017

Record last verified: 2017-04

Locations

PH (2)