Study Stopped
Sponsor decision to close this extension study due to reduction in sample size.
An Extension Trial for Patients With Open-Angle Glaucoma Who Participated in the DF6-CL-20-01 Protocol.
An Extension Trial to Evaluate the Long Term Safety and Effectiveness of the STREAMLINE® SURGICAL SYSTEM in Patients With Open-Angle Glaucoma Who Participated in the DF6-CL-20-01 Protocol.
1 other identifier
observational
17
1 country
1
Brief Summary
The purpose of this study is to evaluate long term safety and effectiveness of the STREAMLINE® SURGICAL SYSTEM
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2024
CompletedFirst Posted
Study publicly available on registry
January 30, 2024
CompletedStudy Start
First participant enrolled
June 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 4, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 4, 2025
CompletedMarch 30, 2026
March 1, 2026
1.5 years
January 19, 2024
March 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in IOP
From Screening to annual endpoints
24months; 36 months; 48months, 60 months
Secondary Outcomes (1)
Number of IOP lowering medications
24months; 36 months; 48months, 60 months
Interventions
STREAMLINE® SURGICAL SYSTEM
Eligibility Criteria
Subjects who participated in the DF6-CL-20-01 trial
You may qualify if:
- participated in the DF6-CL-20-01 trial.
You may not qualify if:
- lost to follow up in the DF6-CL-20-01 trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinica 20/20
San José, Costa Rica
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2024
First Posted
January 30, 2024
Study Start
June 1, 2024
Primary Completion
December 4, 2025
Study Completion
December 4, 2025
Last Updated
March 30, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share