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

Primary Purpose

Open-Angle Glaucoma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VISCO360 ab interno canaloplasty surgery
Selective Laser Trabeculoplasty (SLT)
Sponsored by
Sight Sciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open-Angle Glaucoma

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vold Vision
  • Coastal Vision Medical Group
  • Dean McGee Eye Institute
  • Wills Eye Hospital
  • El Paso Eye Surgeons
  • Ophthalmology Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

VISCO360 ab interno canaloplasty surgery

Selective Laser Trabeculoplasty (SLT)

Arm Description

Subjects randomized to this arm will undergo a surgical procedure in which the VISCO360 Viscosurgical System will be used to microcatheterize and viscodilate Schlemm's canal (i.e., canaloplasty).

Subjects randomized to this arm will undergo the SLT procedure.

Outcomes

Primary Outcome Measures

Mean change in diurnal IOP (Measured in mm Hg)
Measurement is performed at 12 months following wash-out of glaucoma medication

Secondary Outcome Measures

Proportion of subjects achieving a ≥ 20% reduction in mean diurnal IOP
Measurement is performed at 12 months following wash-out of glaucoma medication

Full Information

First Posted
October 6, 2016
Last Updated
February 26, 2019
Sponsor
Sight Sciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02928289
Brief Title
Randomized Study of the Safety and Effectiveness of the Sight Sciences VISCO™360 Viscosurgical System Versus SLT in Primary Open Angle Glaucoma (VISCO360 Study)
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Poor enrollment
Study Start Date
January 23, 2017 (Actual)
Primary Completion Date
January 17, 2019 (Actual)
Study Completion Date
January 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sight Sciences, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-Angle Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VISCO360 ab interno canaloplasty surgery
Arm Type
Active Comparator
Arm Description
Subjects randomized to this arm will undergo a surgical procedure in which the VISCO360 Viscosurgical System will be used to microcatheterize and viscodilate Schlemm's canal (i.e., canaloplasty).
Arm Title
Selective Laser Trabeculoplasty (SLT)
Arm Type
Active Comparator
Arm Description
Subjects randomized to this arm will undergo the SLT procedure.
Intervention Type
Device
Intervention Name(s)
VISCO360 ab interno canaloplasty surgery
Intervention Description
360 degrees of viscodilation of Schlemm's canal
Intervention Type
Device
Intervention Name(s)
Selective Laser Trabeculoplasty (SLT)
Intervention Description
360 degrees of selective laser trabeculoplasty
Primary Outcome Measure Information:
Title
Mean change in diurnal IOP (Measured in mm Hg)
Description
Measurement is performed at 12 months following wash-out of glaucoma medication
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Proportion of subjects achieving a ≥ 20% reduction in mean diurnal IOP
Description
Measurement is performed at 12 months following wash-out of glaucoma medication
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Vold Vision
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72704
Country
United States
Facility Name
Coastal Vision Medical Group
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Dean McGee Eye Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Wills Eye Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
El Paso Eye Surgeons
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Ophthalmology Associates
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76102
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35943114
Citation
Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.
Results Reference
derived

Learn more about this trial

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

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