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

Phase 1

Terminated

• Conditions: Ocular Hypertension (OHT); Primary Open-angle Glaucoma (POAG)
• Interventions: Device: DWT device dose B; Device: DWT device dose A; Device: DWT sham; Device: Ellex Tango SLT machine

• Registration Number: NCT02226094
• Lead Sponsor: OcuTherix, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-08-20
• Study First Submitted QC: 2014-08-22
• Study First Posted: 2014-08-27
• Primary Completion: 2015-06
• Study Completion: 2015-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-03
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DWT device dose B	DWT device dose B	Deep Wave Trabeculoplasty (DWT) dose B (20 second spot treatments).
DWT device dose A	DWT device dose A	Deep Wave Trabeculoplasty (DWT) dose A (10 second spot treatments).
DWT Sham	DWT sham	Deep Wave Trabeculoplasty (DWT) but device not applied to ocular surface.
Ellex Tango SLT machine	Ellex Tango SLT machine	Selective Laser Trabeculoplasty (SLT)

Primary Outcome Measures

Name	Time	Method
Intra-procedural and post-procedural adverse events	6 months
Percent decrease in IOP and change in dependence on IOP-lowering medications from baseline	6 months

Trial Locations

Locations (2)

Pacific Eye and Laser Institute; 🇵🇭 Makati City, Philippines

Asian Eye Institute; 🇵🇭 Makati City, Philippines