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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

Primary Purpose

Open Angle Glaucoma

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Streamline Surgical System
Sponsored by
New World Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open Angle Glaucoma focused on measuring Open Angle Glaucoma, IOP, viscoelastic

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Able to understand and execute written informed consent
  2. Males or female subjects at least 22 years of age.
  3. Subjects qualifying for cataract surgery
  4. Subjects diagnosed with mild to moderate open-angle glaucoma in at least one eye currently treated with 1-3 topical IOP-lowering medications
  5. Subjects with diagnosis of open-angle glaucoma in at least one eye with an unmedicated IOP of 21-36 mmHg

Exclusion Criteria:

  1. Women of child-bearing potential
  2. Modified Shaffer angle grade < 2
  3. Patients with severe or advanced glaucoma
  4. Intraocular surgery within the last 6 months or laser surgery within the last 3 months
  5. BCVA worse than 20/80 in either eye
  6. Patients with a previous peripheral iridotomy.
  7. Ocular infection or inflammation within the last 6 months.
  8. Any medication that would be contraindicated for a glaucoma surgical procedure.

Sites / Locations

  • Clinica 20/20
  • Centro Laser
  • Clinica Laser y Ultrasonido Ocular de Puebla

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Streamline

Arm Description

Streamline Surgical System

Outcomes

Primary Outcome Measures

proportion of unmedicated eyes with IOP reduction of > 20% from Baseline at Month 12.
Primary Endpoint

Secondary Outcome Measures

Adverse Events
Assess intraoperative and post operative AEs
Mean IOP change
Mean IOP change in unmedicated IOP from baseline to M12
Number of topical glaucoma medications
Number of topical glaucoma medications used at screening compared to Month 12

Full Information

First Posted
October 13, 2021
Last Updated
October 11, 2023
Sponsor
New World Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05089474
Brief Title
A First in Human Clinical Trial to Evaluate the Safety and Effectiveness of the STREAMLINE SURGICAL SYSTEM in Patients With Open-Angle Glaucoma
Official Title
A First in Human Clinical Trial to Evaluate the Safety and Effectiveness of the STREAMLINE SURGICAL SYSTEM in Patients With Open-Angle Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 8, 2021 (Actual)
Primary Completion Date
April 20, 2023 (Actual)
Study Completion Date
April 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New World Medical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma
Keywords
Open Angle Glaucoma, IOP, viscoelastic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, non-randomized, open label
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Streamline
Arm Type
Experimental
Arm Description
Streamline Surgical System
Intervention Type
Device
Intervention Name(s)
Streamline Surgical System
Intervention Description
The Streamline System is a device that delivers viscoelastic into Schlemm's Canal.
Primary Outcome Measure Information:
Title
proportion of unmedicated eyes with IOP reduction of > 20% from Baseline at Month 12.
Description
Primary Endpoint
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Assess intraoperative and post operative AEs
Time Frame
12 months
Title
Mean IOP change
Description
Mean IOP change in unmedicated IOP from baseline to M12
Time Frame
12 months
Title
Number of topical glaucoma medications
Description
Number of topical glaucoma medications used at screening compared to Month 12
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Clinica 20/20
City
San José
State/Province
CR
ZIP/Postal Code
10108
Country
Costa Rica
Facility Name
Centro Laser
City
Santo Domingo
State/Province
DR
ZIP/Postal Code
10124
Country
Dominican Republic
Facility Name
Clinica Laser y Ultrasonido Ocular de Puebla
City
Puebla
ZIP/Postal Code
72530
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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