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Travoprost Intraocular Implant + iStent Infinite vs. iStent Infinite Alone

NCT06066645 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2026-01-21

No results posted yet for this study

Summary

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

Conditions

  • Glaucoma, Open-Angle

Interventions

DRUG

Travoprost Intraocular Implant

anchored intracameral implant containing travoprost in subjects who successfully received iStent infinite

OTHER

Sham procedure 1

Sham procedure (to mimic placement of travoprost intraocular implant) in subjects who successfully received iStent infinite

DEVICE

iStent infinite

Successful iStent infinite surgery

OTHER

Sham procedure 2

Sham procedure (to mimic placement of an iStent infinite)

Sponsors & Collaborators

  • Glaukos Corporation

    lead INDUSTRY

Principal Investigators

  • Study Director · Glaukos Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-14
Primary Completion
2027-05-31
Completion
2028-02-29
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06066645 on ClinicalTrials.gov