RecruitingPhase 4NCT06848946

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


Sponsor

Glaukos Corporation

Enrollment

132 participants

Start Date

Jan 13, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 45 Years

Inclusion Criteria2

  • 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 Criteria2

  • Active corneal inflammation or edema.
  • Retinal disorders not associated with glaucoma.

Interventions

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

PROCEDURESham procedure in conjunction with cataract surgery

Sham procedure in conjunction with cataract surgery


Locations(1)

Glaukos Investigator Site

Kenosha, Wisconsin, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06848946


Related Trials