NCT06848946

Safety and Efficacy of iDose® TR With Cataract Surgery vs. Cataract Surgery Alone

Multicenter, Randomized, Double-masked, Parallel Group Trial to Evaluate the Safety and Efficacy of iDose® TR (Travoprost Intracameral Implant) in Conjunction With Cataract Surgery vs. Cataract Surgery Alone

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Glaukos Corporation · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

This trial will evaluate the safety and IOP -lowering efficacy of administering an iDose TR (travoprost intracameral implant) in conjunction with cataract surgery compared to cataract surgery alone

Detailed description

This is a Phase 4 randomized, double-masked, parallel group trial designed to evaluate the safety and IOP-lowering efficacy of administering iDose TR (travoprost intracameral implant 75 mcg) in conjunction with uncomplicated cataract surgery (phacoemulsification with a posterior chamber intraocular lens) compared to uncomplicated cataract surgery alone, in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Conditions

• Glaucoma, Open-angle
• Ocular Hypertension (OHT)
• Phacoemulsification Cataract Surgery

Interventions

Type	Name	Description
COMBINATION_PRODUCT	iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery	iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery
PROCEDURE	Sham procedure in conjunction with cataract surgery	Sham procedure in conjunction with cataract surgery

Timeline

• Start date: 2025-01-13
• Primary completion: 2026-08-01
• Completion: 2027-06-01
• First posted: 2025-02-27
• Last updated: 2026-01-21

Locations

1 site across 1 country: United States

Regulatory

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