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

Phase 4RecruitingNCT06848946

Glaukos Corporation132 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

132

Conditions

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

Interventions

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

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

Sham procedure in conjunction with cataract surgeryPROCEDURE

Sham procedure in conjunction with cataract surgery

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

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.

Locations (1)

Glaukos Investigator Site

Kenosha, Wisconsin, United States

RECRUITING

Outcomes

Primary Outcomes

Change from baseline in mean diurnal IOP

Mean diurnal IOP at the Month 3 Visit minus mean diurnal IOP at the Baseline Visit

Time frame: 3 Months

Central Contacts

Study Manager

CONTACT

949-739-8749 ClinicalResearch@glaukos.com

Data from ClinicalTrials.gov

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