Clinical trial NCT02226094: Safety and Efficacy of Deep Wave Trabeculoplasty (DWT) in Primary Open Angle Glaucoma and Ocular Hypertension
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
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
Lead sponsor: OcuTherix, Inc.
Sponsor class: INDUSTRY
First posted: 2014-08-27
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent decrease in IOP and change in dependence on IOP-lowering medications from baseline
timeFrame: 6 months
measure: Intra-procedural and post-procedural adverse events
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Makati City
country: Philippines
facility: Asian Eye Institute
city: Makati City
country: Philippines
facility: Pacific Eye and Laser Institute
Study officials:
affiliation: Pacific Eye and Laser Institute
name: Harvey Siy Uy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asian Eye Institute
name: Edgar U. Leuenberger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asian Eye Institute
name: Maria I Yap-Veloso, MD
role: PRINCIPAL_INVESTIGATOR
References: