NCT01443988
Completed
Phase 4
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) or Travoprost Ophthalmic Solution 0.004%
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Glaukos Corporation
- Enrollment
- 101
- Locations
- 1
- Primary Endpoint
- Change from screening in mean diurnal IOP (mm Hg) at the Month 12 visit.
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
iStent
Active Comparator
Implantation of two iStent devices
Intervention: iStent (Device)
Drug
Active Comparator
Travoprost drops
Intervention: Travoprost (Drug)
Outcomes
Primary Outcomes
Change from screening in mean diurnal IOP (mm Hg) at the Month 12 visit.
Time Frame: 12 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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