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

NCT06848946 — Phase 4, Recruiting, 132 participants, Glaukos Corporation

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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

Registry	NCT06848946
Status	Recruiting
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	132 (Estimated)
Sponsor	Glaukos Corporation (Industry)
Conditions	Glaucoma, Open-angle, Ocular Hypertension (OHT), Phacoemulsification Cataract Surgery
Interventions	iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery, Sham procedure in conjunction with cataract surgery (Combination product, procedure)
Dates	start 2025-01-13, primary completion 2026-08-01 (estimated), completion 2027-06-01 (estimated), first posted 2025-02-27, last updated 2026-01-21
Locations	1 site in United States

-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

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+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).

+Arms and interventions

Arm	Type	Interventions	Description
iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery	Active comparator	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
Sham procedure in conjunction with cataract surgery	Sham comparator	Procedure: Sham procedure in conjunction with cataract surgery	Sham procedure in conjunction with cataract surgery

iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery (Combination product): iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery
Sham procedure in conjunction with cataract surgery (Procedure): Sham procedure in conjunction with cataract surgery

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 45 Years to any

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)

Facility	City	Country	Status
Glaukos Investigator Site	Kenosha, Wisconsin	United States	Recruiting

+Investigators

Study Director, Study chair, Glaukos Corporation