Recruiting

iDose® TR vs. Cataract Surgery

Sponsor:

Glaukos Corporation

Code:

NCT06848946

Conditions

Glaucoma, Open-angle

Ocular Hypertension (OHT)

Phacoemulsification Cataract Surgery

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Interventions

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

Sham procedure in conjunction with cataract surgery

Study Details

Brief 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

Conditions

Glaucoma, Open-angle

Ocular Hypertension (OHT)

Phacoemulsification Cataract Surgery

Study ID

NCT06848946

Start date

Jan 13, 2025

Status verified date

Jan, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

132 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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 comparator: Sham procedure in conjunction with cataract surgery

Sham procedure in conjunction with cataract surgery

Interventions

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 procedure in conjunction with cataract surgery

Primary outcome measure

  • Change from baseline in mean diurnal IOP [ Time Frame: 3 Months ]

Central Contacts and Locations

Central contacts

Study Manager

949-739-8749ClinicalResearch@glaukos.com

Locations

Glaukos Investigator Site

Recruiting

Kenosha, Wisconsin, United States, 53142

Contacts

idose@glaukos.com

More Information

Sponsor

Glaukos Corporation

Last update posted

Jan 21, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Glaukos Corporation on 2026-01-21.