Trials / Completed
CompletedNCT03654885
XEN-45 Gel Stent Versus Trabeculectomy in Glaucoma: Gold-Standard Pathway Study (GPS)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 158 (actual)
- Sponsor
- Allergan · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This is a multi-center, randomized, parallel group, prospective, open-label clinical trial to evaluate the ability of XEN-45 to reduce intraocular pressure (IOP) and reduce the amount of topical IOP-lowering medications in participants poorly controlled on topical therapy. The planned study duration is 12 months. Participants were to be screened for enrollment and eligible candidates were to be approached to ascertain interest in study participation. Eligible participants were to be randomized 2:1; resulting in approximately 95 eyes implanted with XEN-45 and 44 eyes received trabeculetomy by study end.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | XEN-45 Gel Stent | XEN-45 gel stent device implant |
| PROCEDURE | Trabeculectomy | Trabeculectomy surgery |
Timeline
- Start date
- 2018-10-01
- Primary completion
- 2021-05-13
- Completion
- 2021-05-13
- First posted
- 2018-08-31
- Last updated
- 2022-07-21
- Results posted
- 2022-07-21
Locations
35 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03654885. Inclusion in this directory is not an endorsement.