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

Phase 4

Completed

• Conditions: Open-angle Glaucoma
• Interventions: Device: iStent inject; Drug: Travoprost

• Registration Number: NCT01444040
• Lead Sponsor: Glaukos Corporation

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

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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-28
• Study First Submitted QC: 2011-09-29
• Study First Posted: 2011-09-30
• Primary Completion: 2019-03-28
• Study Completion: 2019-03-28
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-02
• Last Update Posted: 2022-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iStent inject	iStent inject	Implantation of two iStent inject devices
Drug	Travoprost	Travoprost drops

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in screening in time-wise IOPs	Various Month 12-60
Change in mean diurnal IOP vs. screening	Month 24
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.

Trial Locations

Locations (1)

S.V. Malayan Ophthalmological Center; 🇦🇲 Yerevan, Armenia