Randomized Study of the Safety and Effectiveness of the Sight Sciences VISCO™360 Viscosurgical System Versus SLT in Primary Open Angle Glaucoma (VISCO360 Study)

Open-Angle Glaucoma Clinical Trial

Official title:

Multi-Center, Prospective, Randomized, Controlled Clinical Evaluation of the Safety and Effectiveness of the Sight Sciences VISCO™360 Viscosurgical System in Canaloplasty Versus Selective Laser Trabeculoplasty in the Reduction of IOP in Primary Open Angle Glaucoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02928289
• Other study ID #: SIGHTVISCO-001
• Status: Terminated
• Phase: N/A
• Start date: January 23, 2017
• Est. completion date: January 17, 2019

Study information

• Verified date: February 2019
• Source: Sight Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and effectiveness of the Sight Sciences VISCO™360 Viscosurgical System in reducing intraocular pressure (IOP) in adult, pseudophakic subjects with open-angle glaucoma.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: January 17, 2019
• Est. primary completion date: January 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with primary open-angle glaucoma (POAG) in the study eye.

• Pseudophakic with Posterior Chamber IOL (PCIOL)

• Able and willing to attend follow up visits for two years post-operative

• Able and willing to sign informed consent

Exclusion Criteria:

• Phakia or aphakia

• Previous glaucoma procedure with or without an implantable glaucoma device (including incisional surgery, ALT, iridectomy/iridotomy, etc.) [Subjects with one prior SLT application (>3 months prior to screening) or prior ECP (performed > 12 months prior to screening) can be enrolled].

• Use of more than 3 ocular hypotensive medications (combination medications count as 2 medications)

• Diagnosis of acute angle closure, traumatic, congenital, malignant, uveitic, pseudoexfoliative, pigmentary or neovascular glaucoma

• Abnormal angle anatomy as determined by gonioscopy (e.g. peripheral anterior synechiae, rubeosis or other angle abnormalities)

• Participation in any clinical trial = 30 days prior to screening

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Open-Angle Glaucoma

Intervention

Device:
• VISCO360 ab interno canaloplasty surgery
360 degrees of viscodilation of Schlemm's canal
• Selective Laser Trabeculoplasty (SLT)
360 degrees of selective laser trabeculoplasty

Locations

Country	Name	City	State
United States	El Paso Eye Surgeons	El Paso	Texas
United States	Vold Vision	Fayetteville	Arkansas
United States	Ophthalmology Associates	Fort Worth	Texas
United States	Dean McGee Eye Institute	Oklahoma City	Oklahoma
United States	Coastal Vision Medical Group	Orange	California
United States	Wills Eye Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sight Sciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in diurnal IOP (Measured in mm Hg)	Measurement is performed at 12 months following wash-out of glaucoma medication	12 months
Secondary	Proportion of subjects achieving a = 20% reduction in mean diurnal IOP	Measurement is performed at 12 months following wash-out of glaucoma medication	12 months