A First in Human Clinical Trial to Evaluate the Safety and Effectiveness of the STREAMLINE SURGICAL SYSTEM in Patients With Open-Angle Glaucoma

Study Overview
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Brief Summary
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A prospective, nonrandomized, open label study to evaluate the safety and IOP lowering effectiveness of the Streamline Surgical System, in patients with mild-to-moderate open angle glaucoma undergoing cataract surgery.

Detailed Description
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A prospective, nonrandomized, open label study to evaluate the safety and IOP lowering effectiveness of the Streamline Surgical System, a viscoelastic delivery device, in patients with mild-to-moderate open angle glaucoma undergoing cataract surgery. This is a 12 month study conducted outside the US. Approximately 60 subjects will be enrolled.

Official Title
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A First in Human Clinical Trial to Evaluate the Safety and Effectiveness of the STREAMLINE SURGICAL SYSTEM in Patients With Open-Angle Glaucoma

Conditions
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Open Angle Glaucoma

Intervention / Treatment
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* Device: Streamline Surgical System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to understand and execute written informed consent Males or female subjects at least 22 years of age. Subjects qualifying for cataract surgery Subjects diagnosed with mild to moderate open-angle glaucoma in at least one eye currently treated with 1-3 topical IOP-lowering medications Subjects with diagnosis of open-angle glaucoma in at least one eye with an unmedicated IOP of 21-36 mmHg Exclusion Criteria: Women of child-bearing potential Modified Shaffer angle grade < 2 Patients with severe or advanced glaucoma Intraocular surgery within the last 6 months or laser surgery within the last 3 months BCVA worse than 20/80 in either eye Patients with a previous peripheral iridotomy. Ocular infection or inflammation within the last 6 months. Any medication that would be contraindicated for a glaucoma surgical procedure.

Ages Eligible for Study
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Minimum Age: 22 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
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, non-randomized, open label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Streamline<br>Streamline Surgical System | Device: Streamline Surgical System<br>* The Streamline System is a device that delivers viscoelastic into Schlemm's Canal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of unmedicated eyes with IOP reduction of > 20% from Baseline at Month 12. | Primary Endpoint | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Assess intraoperative and post operative AEs | 12 months | 
| Mean IOP change | Mean IOP change in unmedicated IOP from baseline to M12 | 12 months | 
| Number of topical glaucoma medications | Number of topical glaucoma medications used at screening compared to Month 12 | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open Angle Glaucoma, IOP, viscoelastic