- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07816692
iDose TR Administration in an Office-Based Surgery Setting
September 8, 2026 updated by: Glaukos Corporation
Real-World Evidence Observational Study to Evaluate the Safety of iDose® TR (Travoprost Intracameral Implant) 75 µg in an Office-Based Surgery Setting
Clinical in-use observational trial to evaluate the administration of iDose TR (travoprost intracameral implant) in an office-based surgery setting.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
This study is a multicenter, single arm, open-label trial in adult subjects with open-angle glaucoma or ocular hypertension.
The objective of the study is to assess the safety profile of iDose TR administration in an office-based surgery setting.
Study Type
Observational
Enrollment (Estimated)
30
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: 949-739-8749
- Email: ClinicalResearch@glaukos.com
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78746
- Recruiting
- Glaukos Investigative Site
-
Contact:
- Glaukos Investigative Site
- Phone Number: 949-739-8749
- Email: ClinicalResearch@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
Sampling Method
Non-Probability Sample
Study Population
Adults 18 years of age or older with open-angle glaucoma or ocular hypertension
Description
Inclusion Criteria:
- Diagnosis of Open angle glaucoma (OAG) or ocular hypertension (OHT)
Exclusion Criteria:
- Prior administration of iDose TR or administration of an investigational intracameral implant in the study eye Active ocular infection or inflammation History of hypersensitivity to travoprost or implant components Recent ocular surgery Uncontrolled systemic disease Any condition preventing safe implantation
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
iDose TR
Travoprost Intracameral Implant
|
Travoprost-releasing implant preloaded in a sterile, single-use inserter.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Successful administration of iDose TR in an office-based surgical setting.
Time Frame: 3 months
|
Number of subjects that received iDose TR in an office-based surgical setting by the Investigator.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
May 13, 2026
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Study Registration Dates
First Submitted
September 8, 2026
First Submitted That Met QC Criteria
September 8, 2026
First Posted (Actual)
September 14, 2026
Study Record Updates
Last Update Posted (Actual)
September 14, 2026
Last Update Submitted That Met QC Criteria
September 8, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GLK-101-05
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
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.