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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06848946

Enrollment

132

Registered

2025-02-27

Start date

2025-01-13

Completion date

2027-06-01

Last updated

2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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).

Interventions

PROCEDURESham procedure in conjunction with cataract surgery

Sham procedure in conjunction with cataract surgery

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

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Contacts

CONTACTStudy Manager

ClinicalResearch@glaukos.com949-739-8749

STUDY_CHAIRStudy Director

Glaukos Corporation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026