iDose TR Administration in an Office-Based Surgery Setting

Glaukos Corporation30 enrolled

Overview

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

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

Conditions

Open Angle Glaucoma (OAG)Ocular Hypertension (OHT)

Interventions

iDose TR (travoprost intracameral implant) 75 µgCOMBINATION_PRODUCT

Travoprost-releasing implant preloaded in a sterile, single-use inserter.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Glaukos Investigative Site

Austin, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

Successful administration of iDose TR in an office-based surgical setting.

Number of subjects that received iDose TR in an office-based surgical setting by the Investigator.

Time frame: 3 months

Central Contacts

Study Director

CONTACT

949-739-8749 ClinicalResearch@glaukos.com

Data from ClinicalTrials.gov

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