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

Phase 4

Completed

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

• Registration Number: NCT01443988
• Lead Sponsor: Glaukos Corporation

Brief Summary

Evaluation of the intraocular pressure (IOP) lowering effect of two iStent 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 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: 2017-01
• Study Completion: 2017-04
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-14
• Last Update Posted: 2017-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• Phakic study eye
• IOP ≥ 21 mmHg and ≤ 40 mmHg at screening exam (OHT requires second screening)

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	iStent	Implantation of two iStent 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

Trial Locations

Locations (1)

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