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Safety and Efficacy of Deep Wave Trabeculoplasty (DWT) in Primary Open Angle Glaucoma and Ocular Hypertension | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

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

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

NCT02226094•OcuTherix, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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).

Locations (2)

Asian Eye Institute

Makati City, Philippines

Pacific Eye and Laser Institute

Makati City, Philippines

Key Dates

Start Date

November 1, 2013

Primary Completion Date

June 1, 2015

Completion Date

December 1, 2015

Last Updated

April 4, 2017

Enrollment

ACTUAL participants

Conditions

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

Interventions

DWT device dose A

DEVICE

Ellex Tango SLT machine

DEVICE

DWT device dose B

DEVICE

DWT sham

DEVICE

Intraocular Pressure (IOP) Patterns in Fast Versus Slow Visual Field (VF) Progression Patients

NCT01828255

Primary Open-angle Glaucoma (POAG) Patient

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COMPLETEDPHASE4

Prospective Evaluation of Open-Angle Glaucoma Subjects on One Topical Hypotensive Medication Treated With Two iStents

NCT01252862

Subjects With Primary Open-angle Glaucoma (POAG)

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COMPLETEDPHASE2

AL-54478 Proof of Concept Study

NCT01318252

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 4, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Intraocular Pressure (IOP) Patterns in Fast Versus Slow Visual Field (VF) Progression Patients

Prospective Evaluation of Open-Angle Glaucoma Subjects on One Topical Hypotensive Medication Treated With Two iStents

AL-54478 Proof of Concept Study

Single and Multiple Dose Escalation and Two-sequence Crossover Study of ONO-9054 in Patients With Ocular Hypertension or Mild Open-angle Glaucoma