Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent Inject) or Travoprost

A Prospective, Randomized Evaluation of Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent Inject) or Travoprost Ophthalmic Solution 0.004%

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01444040

Enrollment

196

Registered

2011-09-30

Start date

2011-09-30

Completion date

2019-03-28

Last updated

2022-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open-angle Glaucoma

Keywords

Open angle glaucoma, POAG, Ocular hypertension, Pseudoexfoliative glaucoma, Naïve to treatment

Brief summary

Evaluation of the intraocular pressure (IOP) lowering effect of two iStent inject devices versus medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy.

Detailed description

Interventions

DEVICEiStent inject

Implantation of two iStent inject devices

DRUGTravoprost

Travoprost drops

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Phakic study eye * IOP ≥ 21 mmHg and ≤ 40 mmHg at the screening visit (subjects with OHT require a second screening IOP measurement

Exclusion criteria

* Aphakic or pseudophakic eyes (AC-IOLs or PC-IOLs) * Previous usage of topical prostaglandin analogues or prior medical therapy for glaucoma

Design outcomes

Primary

Measure	Time frame
Change from screening in mean diurnal IOP (mm Hg) at the Month 12 visit.	12 months

Secondary

Measure	Time frame	Description
Change in mean diurnal IOP vs. screening	Month 24	—
Change in screening in time-wise IOPs	Various Month 12-60	—
Proportion of responders	Various 12-60 months	A responder is defined as a subject with a certain target IOP value or a certain reduction of IOP as compared to screening. In the iStent inject group, a responder must not be on an ocular hypotensive medications or have had a postoperative procedure to reposition or remove stent(s) prior to the visit. Due to the lack of a complete consensus on the definition of a clinical responder, a set of target IOP values (e.g., downwards from 22 mm Hg in steps of 1 mm Hg) and reductions of IOP (e.g., downwards from the highest reduction in IOP in steps of 5%) will be evaluated.

Other

Measure	Time frame	Description
Adverse event reporting	0-60 months	Rate of ocular adverse events through 60 months * Findings from IOP, best corrected visual acuity, visual field * Findings from slit-lamp, fundus and gonioscopic examinations

Countries

Armenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026