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

Sponsor
New World Medical, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05089474
Collaborator
(none)
60
3
1
23.7
20
0.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Streamline Surgical System
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective, non-randomized, open labelProspective, non-randomized, open label
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 8, 2021
Anticipated Primary Completion Date :
Feb 27, 2023
Anticipated Study Completion Date :
Feb 27, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. proportion of unmedicated eyes with IOP reduction of > 20% from Baseline at Month 12. [12 months]

    Primary Endpoint

Secondary Outcome Measures

  1. Adverse Events [12 months]

    Assess intraoperative and post operative AEs

  2. Mean IOP change [12 months]

    Mean IOP change in unmedicated IOP from baseline to M12

  3. Number of topical glaucoma medications [12 months]

    Number of topical glaucoma medications used at screening compared to Month 12

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinica 20/20 San José CR Costa Rica 10108
2 Centro Laser Santo Domingo DR Dominican Republic 10124
3 Clinica Laser y Ultrasonido Ocular de Puebla Puebla Mexico 72530

Sponsors and Collaborators

  • New World Medical, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
New World Medical, Inc.
ClinicalTrials.gov Identifier:
NCT05089474
Other Study ID Numbers:
  • DF6-CL-20-01
First Posted:
Oct 22, 2021
Last Update Posted:
Oct 22, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by New World Medical, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 22, 2021