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

Last updated: January 19, 2026
Sponsor: Glaukos Corporation
Overall Status: Active - Recruiting

Phase

4

Condition

Vision Loss

Glaucoma

Eye Disease

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:
June 30, 2027

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

    Site Not Available

  • Glaukos Investigator Site

    Kenosha 5258393, Wisconsin 5279468 53142
    United States

    Active - Recruiting

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