Status:
TERMINATED
Safety and Efficacy of Deep Wave Trabeculoplasty (DWT) in Primary Open Angle Glaucoma and Ocular Hypertension
Lead Sponsor:
OcuTherix, Inc.
Conditions:
Primary Open-angle Glaucoma (POAG)
Ocular Hypertension (OHT)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- 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:
- Optic disc or retinal nerve fiber layer structural abnormalities (substantiated by OCT); and/or
- 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:
- Greater than or equal to 18mmHg at the Screening Visit or have documented history of IOP being greater than or equal to 22mmHg;
- 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
- 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
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT02226094
Start Date
November 1 2013
End Date
December 1 2015
Last Update
April 4 2017
Active Locations (2)
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1
Asian Eye Institute
Makati City, Philippines
2
Pacific Eye and Laser Institute
Makati City, Philippines