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
1 other identifier
interventional
132
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2025
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 13, 2025
CompletedFirst Submitted
Initial submission to the registry
February 1, 2025
CompletedFirst Posted
Study publicly available on registry
February 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
January 21, 2026
January 1, 2026
1.5 years
February 1, 2025
January 19, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in mean diurnal IOP
Mean diurnal IOP at the Month 3 Visit minus mean diurnal IOP at the Baseline Visit
3 Months
Study Arms (2)
iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery
ACTIVE COMPARATORiDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery
Sham procedure in conjunction with cataract surgery
SHAM COMPARATORSham procedure in conjunction with cataract surgery
Interventions
Sham procedure in conjunction with cataract surgery
iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Active corneal inflammation or edema.
- Retinal disorders not associated with glaucoma.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Glaukos Investigator Site
Kenosha, Wisconsin, 53142, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Study Director
Glaukos Corporation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2025
First Posted
February 27, 2025
Study Start
January 13, 2025
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
June 1, 2027
Last Updated
January 21, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share