Travoprost Intraocular Implant + iStent Infinite vs. iStent Infinite Alone

Phase 3

Recruiting

• Conditions: Glaucoma, Open-Angle
• Interventions: Other: Sham procedure; Drug: Travoprost Intraocular Implant; Device: iStent infinite

• Registration Number: NCT06066645
• Lead Sponsor: Glaukos Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study Start: 2023-09-14
• Study First Submitted: 2023-09-27
• Study First Submitted QC: 2023-09-27
• Last Update Submitted: 2023-09-27
• Study First Posted: 2023-10-04
• Last Update Posted: 2023-10-04
• Primary Completion: 2025-02
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham procedure	Sham procedure	Sham surgical procedure in subjects who had successful iStent infinite placement
iDose TR	iStent infinite	Travoprost Intraocular Implant in subjects who had successful iStent infinite placement
sham procedure	iStent infinite	Sham surgical procedure in subjects who had successful iStent infinite placement
iDose TR	Travoprost Intraocular Implant	Travoprost Intraocular Implant in subjects who had successful iStent infinite placement

Primary Outcome Measures

Name	Time	Method
change from baseline in mean diurnal intraocular pressure (IOP)	3 months	mean diurnal IOP at the 3 month visit minus mean diurnal IOP at baseline

Trial Locations

Locations (1)

Glaukos Clinical Study Site; 🇺🇸 Colorado Springs, Colorado, United States