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

Part of paid clinical trials in Kenosha, Wisconsin.

Sponsor
Glaukos Corporation
Study ID
NCT06848946
Phase
PHASE4
Status
Recruiting
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Conditions

  • Glaucoma, Open-angle
  • Ocular Hypertension (OHT)
  • Phacoemulsification Cataract Surgery

Eligibility Criteria

Sex
ALL
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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

Key Dates

Start date
Jan 13, 2025
Status verified
Jan 2026
Primary completion
Aug 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
132 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Glaukos Investigator SiteKenoshaWisconsin53142

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Glaukos Investigator Site· Kenosha, WI

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