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

Ocular Hypertension (OHT) Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02226094
• Other study ID #: DWT CIP 002
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: August 20, 2014
• Last updated: April 3, 2017
• Start date: November 2013
• Est. completion date: December 2015

Study information

• Verified date: April 2017
• Source: OcuTherix, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• 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.
• 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.
• DWT device dose B
Same as DWT device dose A except 20 second spot treatments.
• DWT sham
Same as DWT device dose A except device not applied to ocular surface.

Locations

Country	Name	City	State
Philippines	Asian Eye Institute	Makati City
Philippines	Pacific Eye and Laser Institute	Makati City

Sponsors (1)

Lead Sponsor	Collaborator
OcuTherix, Inc.

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent decrease in IOP and change in dependence on IOP-lowering medications from baseline		6 months
Primary	Intra-procedural and post-procedural adverse events		6 months