iDose TR Administration in an Office-Based Surgery Setting

Purpose

Clinical in-use observational trial to evaluate the administration of iDose TR (travoprost intracameral implant) in an office-based surgery setting.

Conditions

  • Open Angle Glaucoma (OAG)
  • Ocular Hypertension (OHT)

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
iDose TR Travoprost Intracameral Implant
  • Combination Product: iDose TR (travoprost intracameral implant) 75 µg
    Travoprost-releasing implant preloaded in a sterile, single-use inserter.
    Other names:
    • iDose TR

Recruiting Locations

Glaukos Investigative Site
Austin, Texas 78746
Contact:
Glaukos Investigative Site
949-739-8749
ClinicalResearch@glaukos.com

More Details

Status
Recruiting
Sponsor
Glaukos Corporation

Study Contact

Study Director
949-739-8749
ClinicalResearch@glaukos.com

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.