Travoprost Intraocular Implant + iStent Infinite vs. iStent Infinite Alone

Glaukos

Status and phase: Enrolling; Phase 3

Conditions: Glaucoma, Open-Angle

Treatments: Drug: Travoprost Intraocular Implant; Device: iStent infinite; Other: Sham procedure 1; Other: Sham procedure 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT06066645

GLK-101-01

Details and patient eligibility

About

Adult subjects with elevated intraocular pressure who have successfully undergone placement of iStent infinite trabecular bypass system will be randomized to receive a travoprost intraocular implant or receive a sham procedure and be followed for 12 months.

Enrollment: 230 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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230 participants in 3 patient groups

iDose TR

Experimental group

Description:

Travoprost Intraocular Implant in subjects who had successful iStent infinite placement

Treatment:

Device: iStent infinite

Drug: Travoprost Intraocular Implant

sham procedure

Sham Comparator group

Description:

Sham surgical procedure

Treatment:

Other: Sham procedure 1

Device: iStent infinite

iDose TR alone

Experimental group

Description:

Travoprost Intraocular Implant

Treatment:

Other: Sham procedure 2

Drug: Travoprost Intraocular Implant