NCT00382395

SOLX Gold Shunt Versus Control Implant: Randomized Trial for Refractory Glaucoma

Randomized, Controlled, Multicenter Comparative Trial to Evaluate the SOLX Gold Shunt for the Reduction of Intraocular Pressure (IOP) in Glaucomatous Eyes Following Failed Medical and Conventional Surgical Treatments

• Status: Suspended
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: SOLX, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Study Objective: To establish the substantial equivalence of the SOLX Gold Shunt to commercially available aqueous shunts, specifically the Ahmed™ Glaucoma Valve Model FP7, in the ability to reduce intraocular pressure (IOP) associated with glaucoma in eyes where medical and conventional surgical treatments have failed.

Detailed description

This protocol is a randomized, controlled, multi-center, outpatient study to compare the IOP lowering ability and safety profile of the SOLX Gold Shunt to the selected, commercially available aqueous shunt product (i.e., Control shunt Model FP7 Ahmed™ Glaucoma Valve Flexible Plate™) for a period of up to one year. Extended follow up is scheduled for a period not to exceed two years, should this be necessary for regulatory purposes. Follow-up beyond one year will be expected unless other patients with SOLX Gold Shunt implants in earlier phase studies outside the US clearly show no significant adverse effects associated with the long-term use of the device for follow-up periods exceeding one year, and this information is deemed adequate to reduce the required follow-up period under this protocol to a shorter period, such as 6 months for the last-to-enter patients at the time of filing for 510(k) marketing clearance review with the FDA.

Conditions

• Glaucoma
• Glaucoma, Open Angle

Interventions

Type	Name	Description
DEVICE	SOLX Gold Shunt GMS-plus	Single use implant
DEVICE	Ahmed FP7 Glaucoma Valve	Single use implant

Timeline

• Start date: 2005-11-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2006-09-29
• Last updated: 2015-09-18

Locations

15 sites across 5 countries: United States, Canada, India, Israel, Poland