SOLX Gold Shunt Versus Control Implant: Randomized Trial for Refractory Glaucoma - Full Text View

Sponsored by:	SOLX, Inc.
Information provided by:	SOLX, Inc.
ClinicalTrials.gov Identifier:	NCT00382395

Purpose

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.

Condition	Intervention	Phase
Glaucoma Glaucoma, Open Angle	Device: SOLX Gold Shunt GMS-plus Device: Ahmed FP7 Glaucoma Valve	Phase III

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by SOLX, Inc.:

Primary Outcome Measures:

Percentage reduction in IOP at both 12 and 24 months after implant [ Time Frame: 1 & 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Absolute IOP [ Time Frame: 1 & 2 years ] [ Designated as safety issue: No ]
Mean number of glaucoma medications [ Time Frame: 1 & 2 years ] [ Designated as safety issue: No ]
Success rate [ Time Frame: 1 & 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	November 2005
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental SOLX Gold Shunt	Device: SOLX Gold Shunt GMS-plus Single use implant
2: Active Comparator Control Ahmed FP7 Shunt	Device: Ahmed FP7 Glaucoma Valve Single use implant

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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Primary open-angle, pseudoexfoliative, or pigmentary glaucoma
Age 21 or over
refractory glaucoma, with IOP >21 mmHg on medications and failed prior incisional glaucoma surgery
detectable visual field defect (negative MD score)
written consent
available for up to 24 months follow-up

Exclusion Criteria:

either eye with VA worse than count fingers
recent angle closure glaucoma episode
uveitic glaucoma, iridocorneal endothelial (ICE) syndrome, traumatic glaucoma, or neovascular glaucoma
other significant ocular disease, except cataract
active ocular infection
expected ocular surgery in next 12 months
no suitable quadrant for implant
systemic corticosteroid therapy > 5 mg/day prednisone
intolerance to gonioscopy or other eye exams
mental impairment interfering with consent or compliance
pregnancy
known sensitivity to anticipated medications used at surgery
significant co-morbid disease
concurrent enrollment in another drug or device study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00382395

Contacts

Contact: Doug Adams	781-547-4051	doug@solx.com
Contact: Joseph Lowery, MBSE	781-547-4055	joe@solx.com

Show 18 Study Locations

Sponsors and Collaborators

SOLX, Inc.

Investigators

Study Director:

Jan S. Peterson, MS, RAC

The EMMES Corporation

More Information

No publications provided

Responsible Party:	SOLX, Inc. ( Doug Adams )
Study ID Numbers:	SLX53
Study First Received:	September 27, 2006
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00382395 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by SOLX, Inc.:

Glaucoma shunt
Ocular implant
Gold
trabeculectomy

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Ocular Hypertension

ClinicalTrials.gov processed this record on May 07, 2009