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

Last updated: February 22, 2025
Sponsor: Glaukos Corporation
Overall Status: Active - Recruiting

Phase

4

Condition

Eye Disease

Eye Disorders/infections

Vision Loss

Treatment

Sham procedure in conjunction with cataract surgery

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

Clinical Study ID

NCT06848946
GLK-101-04
  • Ages > 45
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Cataract diagnosis: clinically significant age-related cataract eligible forphacoemulsification in the study eye.

  • OAG or OHT diagnosis: either OAG (i.e. primary, pseudoexfoliation, or pigmentaryglaucoma) or OHT in the study eye (i.e., eye to undergo cataract surgery)

Exclusion

Exclusion Criteria:

  • Active corneal inflammation or edema.

  • Retinal disorders not associated with glaucoma.

Study Design

Total Participants: 132
Treatment Group(s): 2
Primary Treatment: Sham procedure in conjunction with cataract surgery
Phase: 4
Study Start date:
January 13, 2025
Estimated Completion Date:
September 30, 2026

Study 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).

Connect with a study center

  • Glaukos Investigator Site

    Kenosha, Wisconsin 53142
    United States

    Active - Recruiting

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