Travoprost Intraocular Implant + iStent Infinite vs. iStent Infinite Alone

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-14

Study Completion Date

2028-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Glaucoma, Open-Angle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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iDose TR

Travoprost Intraocular Implant in subjects who had successful iStent infinite placement

Group Type EXPERIMENTAL

Travoprost Intraocular Implant

Intervention Type DRUG

anchored intracameral implant containing travoprost in subjects who successfully received iStent infinite

iStent infinite

Intervention Type DEVICE

Successful iStent infinite surgery

sham procedure

Sham surgical procedure

Group Type SHAM_COMPARATOR

Sham procedure 1

Intervention Type OTHER

Sham procedure (to mimic placement of travoprost intraocular implant) in subjects who successfully received iStent infinite

iStent infinite

Intervention Type DEVICE

Successful iStent infinite surgery

iDose TR alone

Travoprost Intraocular Implant

Group Type EXPERIMENTAL

Travoprost Intraocular Implant

Intervention Type DRUG

anchored intracameral implant containing travoprost in subjects who successfully received iStent infinite

Sham procedure 2

Intervention Type OTHER

Sham procedure (to mimic placement of an iStent infinite)

Interventions

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Travoprost Intraocular Implant

anchored intracameral implant containing travoprost in subjects who successfully received iStent infinite

Intervention Type DRUG

Sham procedure 1

Sham procedure (to mimic placement of travoprost intraocular implant) in subjects who successfully received iStent infinite

Intervention Type OTHER

iStent infinite

Successful iStent infinite surgery

Intervention Type DEVICE

Sham procedure 2

Sham procedure (to mimic placement of an iStent infinite)

Intervention Type OTHER

Other Intervention Names

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iDose TR

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No