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NCT06061718 Clinical Trial

Travoprost Intraocular Implant in Conjunction With Cataract Surgery

Ocular Hypertension Clinical Trial

Official title:
Multicenter, Open-label, Single-arm Trial to Evaluate the Safety and Efficacy of iDose® TR (Travoprost Intraocular Implant) in Conjunction With Cataract Surgery

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06061718
Other study ID # GLK-101-02
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date September 11, 2023
Est. completion date July 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

Subjects with cataract requiring extraction and who have open-angle glaucoma or ocular hypertension will undergo screening and washout from IOP-lowering medication, if applicable. Eligible subjects who meet all inclusion criteria and none of the exclusion criteria and who undergo successful cataract extraction with implantation of a posterior chamber intraocular lens (PC-IOL) will receive a travoprost intraocular implant and followed up for 12 months.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date July 2025
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 45 Years and older
Eligibility Inclusion Criteria: - clinically significant age-related cataract eligible for phacoemulsification in the study eye - open-angle glaucoma or ocular hypertension in the study eye - successful, uncomplicated cataract surgery using small incision phacoemulsification cataract surgery and insertion of a foldable posterior chamber IOL 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 the fellow 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:
• iDose TR
anchored intracameral implant containing travoprost

Locations
Country Name City State
Armenia Glaukos Clinical Study Site Yerevan

Sponsors (1)
Lead Sponsor Collaborator
Glaukos Corporation

Country where clinical trial is conducted

Armenia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in mean diurnal IOP Mean diurnal IOP at the Month 3 Visit minus the mean diurnal IOP at the Baseline Visit 3 months
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