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

Phase 4

Recruiting

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

• Registration Number: NCT06848946
• Lead Sponsor: Glaukos Corporation

Brief 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).

Study Timeline

• Study Start: 2025-01-13
• Status Verified: 2025-02
• Study First Submitted: 2025-02-01
• Study First Submitted QC: 2025-02-22
• Last Update Submitted: 2025-02-22
• Study First Posted: 2025-02-27
• Last Update Posted: 2025-02-27
• Primary Completion: 2025-12
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• Cataract diagnosis: clinically significant age-related cataract eligible for phacoemulsification in the study eye.
• OAG or OHT diagnosis: either OAG (i.e. primary, pseudoexfoliation, or pigmentary glaucoma) or OHT in the study eye (i.e., eye to undergo cataract surgery)

Exclusion Criteria

• Active corneal inflammation or edema.
• Retinal disorders not associated with glaucoma.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in mean diurnal IOP	3 Months	Mean diurnal IOP at the Month 3 Visit minus mean diurnal IOP at the Baseline Visit

Trial Locations

Locations (1)

Glaukos Investigator Site; 🇺🇸 Kenosha, Wisconsin, United States