Glaukos® iStent Infinite Trabecular Micro-Bypass System i... | NCT06057051

Studies
Glaukos® iStent Infinite Trabecular Micro-Bypass System in Subjects With Mild to Moderate Primary Open-angle Glaucoma

NCT06057051

Sponsor

Glaukos Corporation

Status

Recruiting

Last Update Posted

Sep 28, 2023Actual

Enrollment

245Estimated

Phase

Not Applicable

Conditions

Glaucoma

Interventions

iStent Infinite

Countries

United States

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 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2023Actual

Primary Completion Date

Aug 2025Estimated

Completion Date

Aug 2027Estimated

First Submitted Date

Sep 21, 2023

First Submission Date that Met QC Criteria

Sep 21, 2023

First Posted Date

Sep 28, 2023Actual

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 26, 2023

Last Update Posted Date

Sep 28, 2023Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Prospective, multicenter, single-arm study of the iStent infinite in adult pseudophakic or phakic subjects with mild to moderate primary open angle glaucoma who have not failed conventional medical and surgical treatment

Detailed Description

Not provided

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

245Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
iStent Infinite	Experimental	iStent Infinite Trabecular Micro-Bypass System	Device: iStent Infinite

Interventions

Name	Type	Description	Arm Group Labels	Other Names
iStent Infinite	Device	iStent Infinite Trabecular Micro-Bypass System	iStent Infinite

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Diurnal Intraocular Pressure (IOP) 12-Month reduction ≥ 20% from Baseline		12 Months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of primary open-angle glaucoma
Phakic or pseudophakic
Age 35 years or older

Exclusion Criteria:

Traumatic, uveitic, neovascular, angle-closure glaucoma or
glaucoma associated with vascular disorders
Active corneal inflammation or edema
Retinal disorders not associated with glaucoma

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dari Parizadeh	Contact	949-481-0575		dparizadeh@glaukos.com
Kerry Stephens	Contact	949-481-8057		kstephens@glaukos.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Glaukos Investigator Site	Recruiting	Cincinnati	Ohio	45242	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided