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NCT06066645 Clinical Trial

Travoprost Intraocular Implant + iStent Infinite vs. iStent Infinite Alone

Glaucoma, Open-Angle Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06066645
Other study ID # GLK-101-01
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date September 14, 2023
Est. completion date November 2025

Study information
Verified date September 2023
Source Glaukos Corporation
Contact Study Director
Phone 949-481-8076
Email idose@glaukos.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date November 2025
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Travoprost Intraocular Implant
anchored intracameral implant containing travoprost in subjects who successfully received iStent infinite
Other:
• Sham procedure
Sham procedure (to mimic placement of travoprost intraocular implant) in subjects who successfully received iStent infinite
Device:
• iStent infinite
Successful iStent infinite surgery

Locations
Country Name City State
United States Glaukos Clinical Study Site Colorado Springs Colorado

Sponsors (1)
Lead Sponsor Collaborator
Glaukos Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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