Travoprost Intraocular Implant + iStent Infinite
Multicenter, Randomized, Double-masked Trial to Evaluate the Safety and Efficacy of iDose® TR (Travoprost Intraocular Implant) in Conjunction With the Placement of iStent Infinite in Subjects With Open-angle Glaucoma or Ocular Hypertension
1 other identifier
interventional
150
1 country
1
Brief Summary
Adult subjects with elevated intraocular pressure will be randomized to receive iStent infinite trabecular bypass system plus a travoprost intraocular implant or receive a sham procedure plus a travoprost intraocular implant and be followed for 12 months.
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 Sep 2023
Longer than P75 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
September 14, 2023
CompletedFirst Submitted
Initial submission to the registry
September 27, 2023
CompletedFirst Posted
Study publicly available on registry
October 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
June 2, 2026
May 1, 2026
3.6 years
September 27, 2023
May 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
change from baseline in mean diurnal intraocular pressure (IOP)
mean diurnal IOP at the 3 month visit minus mean diurnal IOP at baseline
3 months
Study Arms (2)
iDose TR
EXPERIMENTALTravoprost Intraocular Implant in subjects who had successful iStent infinite placement
iDose TR alone
ACTIVE COMPARATORTravoprost Intraocular Implant
Interventions
anchored intracameral implant containing travoprost
Eligibility Criteria
You may qualify if:
- diagnosis of open-angle glaucoma or ocular hypertension
- qualifying IOP in the study eye
You may not qualify if:
- unmedicated (washed out) IOP of \>36 mmHg in the study eye
- hypersensitivity to travoprost or any other components of the travoprost intraocular implant
- vertical cup/disc ratio \> 0.8 in the study eye
- best spectacle corrected visual acuity of worse than 20/80 in either eye
- any ocular disease or condition that, in the opinion of the investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Glaukos Clinical Study Site
Oklahoma City, Oklahoma, 73112, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
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
September 27, 2023
First Posted
October 4, 2023
Study Start
September 14, 2023
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
February 1, 2028
Last Updated
June 2, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share