Ocular Hypertension (OHT), Open Angle Glaucoma (OAG)
Conditions
Keywords
Glaucoma, Ocular Hypertension
Brief summary
Clinical in-use observational trial to evaluate the administration of iDose TR (travoprost intracameral implant) in an office-based surgery setting.
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.
Interventions
COMBINATION_PRODUCTiDose TR (travoprost intracameral implant) 75 µg
Travoprost-releasing implant preloaded in a sterile, single-use inserter.
Sponsors
Glaukos Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful administration of iDose TR in an office-based surgical setting. | 3 months | Number of subjects that received iDose TR in an office-based surgical setting by the Investigator. |
Countries
United States
Contacts
CONTACTStudy Director
Outcome results
None listed