Travoprost Intraocular Implant + iStent Infinite | NCT06066645

Studies
Travoprost Intraocular Implant + iStent Infinite

NCT06066645

Sponsor

Glaukos Corporation

Status

Recruiting

Last Update Posted

Jun 2, 2026Actual

Enrollment

150Estimated

Phase

Phase 4

Conditions

Glaucoma, Open-Angle

Interventions

Travoprost Intraocular Implant
iStent infinite
Sham procedure

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

May 2026

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 14, 2023Actual

Primary Completion Date

May 2027Estimated

Completion Date

Feb 2028Estimated

First Submitted Date

Sep 27, 2023

First Submission Date that Met QC Criteria

Sep 27, 2023

First Posted Date

Oct 4, 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

May 29, 2026

Last Update Posted Date

Jun 2, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

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

Adult subjects with elevated intraocular pressure will be randomized to receive iStent infinite trabecular bypass system plus a travoprost intraocular implant or receive a sham procedure plus a travoprost intraocular implant and be followed for 12 months.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
iDose TR	Experimental	Travoprost Intraocular Implant in subjects who had successful iStent infinite placement	Drug: Travoprost Intraocular Implant Device: iStent infinite
iDose TR alone	Active Comparator	Travoprost Intraocular Implant	Drug: Travoprost Intraocular Implant Other: Sham procedure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Travoprost Intraocular Implant	Drug	anchored intracameral implant containing travoprost	iDose TR iDose TR alone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change from baseline in mean diurnal intraocular pressure (IOP)	mean diurnal IOP at the 3 month visit minus mean diurnal IOP at baseline	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosis of open-angle glaucoma or ocular hypertension
qualifying IOP in the study eye

Exclusion Criteria:

unmedicated (washed out) IOP of >36 mmHg in the study eye
hypersensitivity to travoprost or any other components of the travoprost intraocular implant
vertical cup/disc ratio > 0.8 in the study eye
best spectacle corrected visual acuity of worse than 20/80 in either eye
any ocular disease or condition that, in the opinion of the investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study

Accepts Healthy Volunteers

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

Name	Role	Phone	Extension	Email
Study Director	Contact	949-739-8749		idoseclinical@glaukos.com
Study Manager	Contact	949-739-8749		idoseclinical@glaukos.com

Overall Officials

Name	Affiliation	Role
Study Director	Glaukos Corporation	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Glaukos Clinical Study Site	Recruiting	Oklahoma City	Oklahoma	73112	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
D005902	Glaucoma, Open-Angle

Ancestor Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided