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NCT03654885 · ClinicalTrials.gov registry record · Phase 4
XEN-45 Gel Stent Versus Trabeculectomy in Glaucoma: Gold-Standard Pathway Study (GPS)
A Phase 4 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 4
- Development phase
- 158
- Enrollment target
NCT03654885: Completed Phase 4 study, sponsored by Allergan.
NCT03654885 is a Phase 4 study that has completed, run by Allergan. The registered enrollment target is 158 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03654885, a Phase 4 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 158 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the safety and efficacy of XEN-45 to trabeculectomy in participants with open angle glaucoma refractory to topical medical therapy.
Primary Outcome
IOP is a measure of the fluid pressure inside the eye. In addition to achieving a 20% reduction of IOP from Baseline, the participants had to meet all of the following prespecified caveats at Month 12: no increase in the number of topical IOP-lowering medications compared to Baseline, no clinical hypotony, no loss of vision to count fingers or worse, and no secondary glaucoma surgical intervention.
Interventions
- PROCEDURE Trabeculectomy
- DEVICE XEN-45 Gel Stent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2021-05-13 |
| Phase | Phase 4 |
What the finished NCT03654885 record still lists
NCT03654885 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 2 interventions - of which Trabeculectomy is the first listed.
NCT03654885 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03654885 about?
NCT03654885 is a clinical study titled "XEN-45 Gel Stent Versus Trabeculectomy in Glaucoma: Gold-Standard Pathway Study (GPS)". The purpose of this study is to compare the safety and efficacy of XEN-45 to trabeculectomy in participants with open angle glaucoma refractory to topical medical therapy.
What is the current status of trial NCT03654885?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 158 participants. The study started on 2018-10-01. Estimated completion is 2021-05-13.
What interventions are being tested in trial NCT03654885?
The interventions under investigation include: Trabeculectomy (PROCEDURE), XEN-45 Gel Stent (DEVICE).
Who is sponsoring clinical trial NCT03654885?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03654885's enrollment target sits among peer trials
158 516th of 2000 higher than 1,482 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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