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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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%

Conditions
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Open-angle Glaucoma

Intervention / Treatment
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* Device: iStent inject
* Drug: Travoprost


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: iStent inject<br>Implantation of two iStent inject devices | Device: iStent inject<br>* Implantation of two iStent inject devices<br>|
| Active Comparator: Drug<br>Travoprost drops | Drug: Travoprost<br>* Travoprost drops<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from screening in mean diurnal IOP (mm Hg) at the Month 12 visit. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean diurnal IOP vs. screening |  | Month 24 | 
| Change in screening in time-wise IOPs |  | Various Month 12-60 | 
| Proportion of responders | 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. | Various 12-60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open angle glaucoma, POAG, Ocular hypertension, Pseudoexfoliative glaucoma, Naïve to treatment