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

Sponsor

Glaukos Corporation (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01444040

Collaborator

(none)

200

Enrollment

Location

Arms

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Open-angle Glaucoma	Device: iStent inject Drug: Travoprost	Phase 4

Detailed Description

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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%

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

May 1, 2017

Anticipated Study Completion Date :

Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: iStent inject Implantation of two iStent inject devices	Device: iStent inject Implantation of two iStent inject devices
Active Comparator: Drug Travoprost drops	Drug: Travoprost Travoprost drops

Arm

Intervention/Treatment

Active Comparator: iStent inject

Implantation of two iStent inject devices

Device: iStent inject

Implantation of two iStent inject devices

Active Comparator: Drug

Travoprost drops

Drug: Travoprost

Travoprost drops

Outcome Measures

Primary Outcome Measures

Change from screening in mean diurnal IOP (mm Hg) at the Month 12 visit. [12 months]

Secondary Outcome Measures

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 Outcome Measures

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