Back to resultsTravoprost Intraocular Implant + iStent Infinite vs. iStent Infinite Alone
Primary Purpose
Glaucoma, Open-Angle
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Travoprost Intraocular Implant
Sham procedure
iStent infinite
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma, Open-Angle
Eligibility Criteria
Inclusion Criteria: diagnosis of open-angle glaucoma or ocular hypertension qualifying IOP in the study eye Exclusion Criteria: 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 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
Sites / Locations
- Glaukos Clinical Study SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
iDose TR
sham procedure
Arm Description
Travoprost Intraocular Implant in subjects who had successful iStent infinite placement
Sham surgical procedure in subjects who had successful iStent infinite placement
Outcomes
Primary Outcome Measures
change from baseline in mean diurnal intraocular pressure (IOP)
mean diurnal IOP at the 3 month visit minus mean diurnal IOP at baseline
Secondary Outcome Measures
Full Information
NCT ID
NCT06066645
First Posted
September 27, 2023
Last Updated
September 27, 2023
Sponsor
Glaukos Corporation
1. Study Identification
Unique Protocol Identification Number
NCT06066645
Brief Title
Travoprost Intraocular Implant + iStent Infinite vs. iStent Infinite Alone
Official Title
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 vs. iStent Infinite Alone in Subjects With Open-angle Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2023 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glaukos Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Adult subjects with elevated intraocular pressure who have successfully undergone placement of iStent infinite trabecular bypass system will be randomized to receive a travoprost intraocular implant or receive a sham procedure and be followed for 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
iDose TR
Arm Type
Experimental
Arm Description
Travoprost Intraocular Implant in subjects who had successful iStent infinite placement
Arm Title
sham procedure
Arm Type
Sham Comparator
Arm Description
Sham surgical procedure in subjects who had successful iStent infinite placement
Intervention Type
Drug
Intervention Name(s)
Travoprost Intraocular Implant
Other Intervention Name(s)
iDose TR
Intervention Description
anchored intracameral implant containing travoprost in subjects who successfully received iStent infinite
Intervention Type
Other
Intervention Name(s)
Sham procedure
Intervention Description
Sham procedure (to mimic placement of travoprost intraocular implant) in subjects who successfully received iStent infinite
Intervention Type
Device
Intervention Name(s)
iStent infinite
Intervention Description
Successful iStent infinite surgery
Primary Outcome Measure Information:
Title
change from baseline in mean diurnal intraocular pressure (IOP)
Description
mean diurnal IOP at the 3 month visit minus mean diurnal IOP at baseline
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of open-angle glaucoma or ocular hypertension
qualifying IOP in the study eye
Exclusion Criteria:
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Director
Phone
949-481-8076
Email
idose@glaukos.com
First Name & Middle Initial & Last Name or Official Title & Degree
Study Manager
Phone
949-481-8076
Email
idose@glaukos.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Glaukos Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Glaukos Clinical Study Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Director
Phone
949-481-8076
Email
idose@Glaukos.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Travoprost Intraocular Implant + iStent Infinite vs. iStent Infinite Alone
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