Travoprost Intraocular Implant + iStent Infinite
Recruiting · NCT06066645 · Interventional (participants receive a specific treatment) · Lead sponsor: Glaukos Corporation
View the official record on ClinicalTrials.gov →Interventions studied
Sham procedureTravoprost Intraocular ImplantiStent infinite
What this trial is about
Adult subjects with elevated intraocular pressure will be randomized to receive iStent infinite trabecular bypass system plus a travoprost intraocular implant or receive a sham procedure plus a travoprost intraocular implant and be followed for 12 months.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- diagnosis of open-angle glaucoma or ocular hypertension
- qualifying IOP in the study eye
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 either 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
Where it is running
1 location listed across 1 US state.
- Glaukos Clinical Study Site - Oklahoma City, Oklahoma, United States