- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06061718
Travoprost Intraocular Implant in Conjunction With Cataract Surgery
September 25, 2023 updated by: Glaukos Corporation
Multicenter, Open-label, Single-arm Trial to Evaluate the Safety and Efficacy of iDose® TR (Travoprost Intraocular Implant) in Conjunction With Cataract Surgery
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Study Director
- Phone Number: 949-481-8076
- Email: idose@Glaukos.com
Study Locations
-
-
-
Yerevan, Armenia
- Recruiting
- Glaukos Clinical Study Site
-
Contact:
- Study Director
- Phone Number: 949-481-8076
- Email: idose@Glaukos.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: iDose TR
Travoprost Intraocular Implant administered intracamerally in the study eye at the Day 1 Visit following successful cataract surgery
|
anchored intracameral implant containing travoprost
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in mean diurnal IOP
Time Frame: 3 months
|
Mean diurnal IOP at the Month 3 Visit minus the mean diurnal IOP at the Baseline Visit
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Study Director, Glaukos Corporation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 11, 2023
Primary Completion (Estimated)
September 1, 2024
Study Completion (Estimated)
July 1, 2025
Study Registration Dates
First Submitted
September 25, 2023
First Submitted That Met QC Criteria
September 25, 2023
First Posted (Actual)
September 29, 2023
Study Record Updates
Last Update Posted (Actual)
September 29, 2023
Last Update Submitted That Met QC Criteria
September 25, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GLK-101-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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