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
Overview
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.
Full Title of Study: “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%”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: January 2017
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.
Interventions
- Device: iStent
- Implantation of two iStent devices
- Drug: Travoprost
- Travoprost drops
Arms, Groups and Cohorts
- Active Comparator: iStent
- Implantation of two iStent devices
- Active Comparator: Drug
- Travoprost drops
Clinical Trial Outcome Measures
Primary Measures
- Change from screening in mean diurnal IOP (mm Hg) at the Month 12 visit.
- Time Frame: 12 months
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Glaukos Corporation
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Lilit A Voskanyan, MD, PhD, Principal Investigator, S.V. Malayan Ophthalmological Center, Yerevan, Armenia
References
Vold SD, Voskanyan L, Tetz M, Auffarth G, Masood I, Au L, Ahmed II, Saheb H. Newly Diagnosed Primary Open-Angle Glaucoma Randomized to 2 Trabecular Bypass Stents or Prostaglandin: Outcomes Through 36 Months. Ophthalmol Ther. 2016 Dec;5(2):161-172. doi: 10.1007/s40123-016-0065-3. Epub 2016 Sep 12. Erratum In: Ophthalmol Ther. 2016 Dec;5(2):173.
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.