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

Open Angle Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05089474
• Other study ID #: DF6-CL-20-01
• Status: Completed
• Phase: N/A
• Start date: March 8, 2021
• Est. completion date: April 20, 2023

Study information

• Verified date: January 2023
• Source: New World Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 20, 2023
• Est. primary completion date: April 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Open Angle Glaucoma

Intervention

Device:
• Streamline Surgical System
The Streamline System is a device that delivers viscoelastic into Schlemm's Canal.

Locations

Country	Name	City	State
Costa Rica	Clinica 20/20	San José	CR
Dominican Republic	Centro Laser	Santo Domingo	DR
Mexico	Clinica Laser y Ultrasonido Ocular de Puebla	Puebla

Sponsors (1)

Lead Sponsor	Collaborator
New World Medical, Inc.

Countries where clinical trial is conducted

Costa Rica,  Dominican Republic,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of unmedicated eyes with IOP reduction of > 20% from Baseline at Month 12.	Primary Endpoint	12 months
Secondary	Adverse Events	Assess intraoperative and post operative AEs	12 months
Secondary	Mean IOP change	Mean IOP change in unmedicated IOP from baseline to M12	12 months
Secondary	Number of topical glaucoma medications	Number of topical glaucoma medications used at screening compared to Month 12	12 months