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A Prospective Evaluation of Glaucoma Subjects Treated With Two Second Generation iStents and One iStent Supra (GCF-041)

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ClinicalTrials.gov Identifier: NCT03255798
Recruitment Status : Recruiting
First Posted : August 21, 2017
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation

Brief Summary:
Prospective Evaluation of Open-Angle Glaucoma Subjects treated with two second generation iStents and one iStent Supra

Condition or disease Intervention/treatment Phase
Glaucoma, Open-Angle Device: G2 and G3 Phase 4

Detailed Description:
Prospective Evaluation of Mild to Moderate Open-Angle Glaucoma Subjects treated with Two Second Generation Microbypass Stents and One Suprachoroidal Stent

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: G2 and G3
Masking: None (Open Label)
Masking Description: IOP outcome is masked
Primary Purpose: Treatment
Official Title: A Prospective Evaluation of Mild to Moderate Open-Angle Glaucoma Subjects Treated With Two Second Generation Micro-bypass Stents and One Suprachoroidal Stent
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
G2 and G3 implantation
Two iStent inject stents and one iStent Supra stent
Device: G2 and G3
Two iStent inject devices and one iStent supra device




Primary Outcome Measures :
  1. 20% IOP reduction [ Time Frame: Month 12 ]
    IOP reduction observed compared to baseline IOP, measured by Goldmann tonometry in mm Hg


Secondary Outcome Measures :
  1. IOP less than or equal to 18 mm Hg [ Time Frame: Month 12 ]
    IOP compared to baseline IOP, measured by Goldmann tonometry in mm Hg



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Phakic or pseudophakic subjects with posterior chamber IOLs Primary open-angle glaucoma or pseudoexfoliative glaucoma diagnosis Subject on two ocular hypotensive medications Medicated screening IOP greater than or equal to 18 mm Hg and less than or equal to 30 mm Hg Visual field or optic nerve defect characteristic of glaucoma Normal iridocorneal angle anatomy Absence of peripheral anterior synechiae Mean diurnal IOP at baseline between 21 and 45 mm Hg

Exclusion Criteria:

  • Subjects with anterior chamber IOLs Prior SLT or stent implantation in study eye Traumatic, uveitic, or neovascular glaucoma Fellow eye BCVA worse than 20/200

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03255798


Contacts
Contact: Jeff Wells, PharmD 949-482-0042 ext 1227 jwells@glaukos.com
Contact: Harald Fuchs, PhD hfuchs@glaukos.com

Locations
Germany
Fritz Hengerer, MD Recruiting
Heidelberg, Germany
Contact: Fritz Hengerer, MD         
Sponsors and Collaborators
Glaukos Corporation
Investigators
Study Director: Jeff Wells, PharmD Glaukos Corporation

Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT03255798     History of Changes
Other Study ID Numbers: GCF-041
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases