NCT06066645

Travoprost Intraocular Implant + iStent Infinite vs. iStent Infinite Alone

Multicenter, Randomized, Double-masked Trial to Evaluate the Safety and Efficacy of iDose® TR (Travoprost Intraocular Implant) in Conjunction With the Placement of iStent Infinite vs. iStent Infinite Alone in Subjects With Open-angle Glaucoma or Ocular Hypertension

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: Glaukos Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2023-09-14
• Primary completion: 2027-05-01
• Completion: 2028-02-01
• First posted: 2023-10-04
• Last updated: 2026-01-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study