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

October 11, 2023 updated by: New World Medical, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Costa Rica
    • CR
      • San José, CR, Costa Rica, 10108
        • Clinica 20/20
  • Dominican Republic
    • DR
      • Santo Domingo, DR, Dominican Republic, 10124
        • Centro Laser
  • Mexico
      • Puebla, Mexico, 72530
        • Clinica Laser y Ultrasonido Ocular de Puebla

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New World Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2021

Primary Completion (Actual)

April 20, 2023

Study Completion (Actual)

April 20, 2023

Study Registration Dates

First Submitted

October 13, 2021

First Submitted That Met QC Criteria

October 21, 2021

First Posted (Actual)

October 22, 2021

Study Record Updates

Last Update Posted (Actual)

October 13, 2023

Last Update Submitted That Met QC Criteria

October 11, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DF6-CL-20-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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