Travoprost Intraocular Implant + iStent Infinite
ConditionGlaucoma, Open-Angle
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorGlaukos Corporation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
diagnosis of open-angle glaucoma or ocular hypertension
qualifying IOP in the study eye
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Travoprost Intraocular Implant
Druganchored intracameral implant containing travoprost
iStent infinite
DeviceSuccessful iStent infinite surgery
Sham procedure
Other interventionSham procedure (to mimic placement of an iStent infinite)
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: iDose TRExperimental treatment 2 interventions
Group B: iDose TR aloneActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
change from baseline in mean diurnal intraocular pressure (IOP)
mean diurnal IOP at the 3 month visit minus mean diurnal IOP at baseline
Time frame
3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov