Glaucoma, Open-Angle
Conditions
Brief summary
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.
Interventions
DRUGTravoprost Intraocular Implant
anchored intracameral implant containing travoprost
DEVICEiStent infinite
Successful iStent infinite surgery
OTHERSham procedure
Sham procedure (to mimic placement of an iStent infinite)
Sponsors
Glaukos Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline in mean diurnal intraocular pressure (IOP) | 3 months | mean diurnal IOP at the 3 month visit minus mean diurnal IOP at baseline |
Countries
United States
Contacts
CONTACTStudy Director
CONTACTStudy Manager
STUDY_DIRECTORStudy Director
Glaukos Corporation
Outcome results
None listed