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OpenTrials
Recruiting

NCT Number: NCT06848946

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

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

Recruiting

Interested in participating?

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Key information

Conditions

Glaucoma, Open-Angle Eye Diseases Glaucoma Ocular Hypertension Ocular Hypertension (OHT) Phacoemulsification Cataract Surgery

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Glaukos Investigator Site

Kenosha, Wisconsin, 53142, United States

Location status: Recruiting

Location contact

CONTACT

[email protected]

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Change from baseline in mean diurnal IOP

    Time frame: 3 Months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Study Manager

CONTACT

[email protected]

949-739-8749

Sponsors and collaborators

Lead sponsor

Glaukos Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 27, 2025
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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