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XEN-45 Gel Stent Versus Trabeculectomy in Glaucoma: Gold-Standard Pathway Study (GPS) — XEN GPS  

Glaucoma Clinical Trial

Official title:
XEN-45 Gel Stent Versus Trabeculectomy in Glaucoma: Gold-Standard Pathway Study (GPS)

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03654885
Study type Interventional
Source Allergan
Contact
Status Completed
Phase Phase 4
Start date October 1, 2018
Completion date May 13, 2021
View Details
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