iStent Inject in OAG Subjects on 2 Pre-op Topical Ocular... | NCT03478293

Studies
iStent Inject in OAG Subjects on 2 Pre-op Topical Ocular Hypotensive Medications

NCT03478293

Sponsor

Glaukos Corporation

Status

Terminated

Last Update Posted

Sep 9, 2022Actual

Enrollment

6Actual

Phase

Not Applicable

Conditions

Primary Open Angle Glaucoma (POAG)

Interventions

iStent inject surgery

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Business Decision

Expanded Access Info

Start Date

Feb 27, 2018Actual

Primary Completion Date

Dec 30, 2020Actual

Completion Date

Dec 30, 2020Actual

First Submitted Date

Mar 20, 2018

First Submission Date that Met QC Criteria

Mar 20, 2018

First Posted Date

Mar 27, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 6, 2022

Last Update Posted Date

Sep 9, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of iStent inject in eyes of subjects with primary open-angle glaucoma previously on two anti-glaucoma medications.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
iStent inject surgery	Experimental	Single-arm study. Intervention is micro-invasive glaucoma surgery (MIGS) to implant iStent inject	Device: iStent inject surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
iStent inject surgery	Device	Micro-invasive glaucoma surgery (MIGS) to implant iStent inject	iStent inject surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
IOP reduction at 12 and 24 months on same number or fewer medications	IOP reduction at 12 and 24 months on same number or fewer medications	12 months and 24 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed with primary open angle glaucoma (POAG)
Subject on two ocular hypotensive medications

Exclusion Criteria:

Traumatic, uveitic, neovascular, or angle closure glaucoma
Fellow eye already enrolled

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kerry Stephens, OD	Glaukos Corporation	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ophthalmology - UNIFESP/ Hospital São Paulo		São Paulo		04023-62	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle

Ancestor Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided