NCT06848946PHASE4Recruiting

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

Glaukos Corporation

Start Date

1/13/2025

Completion Date

6/1/2027

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).

Eligibility Criteria

Age Range: 45 years to No maximum

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.

Interventions

COMBINATION_PRODUCT

iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery

PROCEDURE

Sham procedure in conjunction with cataract surgery

Interested in This Trial?

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Conditions

Glaucoma, Open-angleOcular Hypertension (OHT)Phacoemulsification Cataract Surgery

Locations

Glaukos Investigator Site

Kenosha, Wisconsin 53142

United States