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

OcuTherix

Status and phase: Terminated; Phase 2; Phase 1

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

Treatments: Device: DWT device dose B; Device: Ellex Tango SLT machine; Device: DWT sham; Device: DWT device dose A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02226094

DWT CIP 002

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 4 patient groups

DWT device dose A

Experimental group

Description:

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

Treatment:

Device: DWT device dose A

Ellex Tango SLT machine

Active Comparator group

Description:

Selective Laser Trabeculoplasty (SLT)

Treatment:

Device: Ellex Tango SLT machine

DWT Sham

Sham Comparator group

Description:

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

Treatment:

Device: DWT sham

DWT device dose B

Experimental group

Description:

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

Treatment:

Device: DWT device dose B