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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02928289
Recruitment Status : Terminated (Poor enrollment)
First Posted : October 10, 2016
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Sight Sciences, Inc.

Tracking Information
First Submitted Date  ICMJE October 6, 2016
First Posted Date  ICMJE October 10, 2016
Last Update Posted Date February 28, 2019
Actual Study Start Date  ICMJE January 23, 2017
Actual Primary Completion Date January 17, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2016)
Mean change in diurnal IOP (Measured in mm Hg) [ Time Frame: 12 months ]
Measurement is performed at 12 months following wash-out of glaucoma medication
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02928289 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2016)
Proportion of subjects achieving a ≥ 20% reduction in mean diurnal IOP [ Time Frame: 12 months ]
Measurement is performed at 12 months following wash-out of glaucoma medication
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Open-Angle Glaucoma
Intervention  ICMJE
  • Device: VISCO360 ab interno canaloplasty surgery
    360 degrees of viscodilation of Schlemm's canal
  • Device: Selective Laser Trabeculoplasty (SLT)
    360 degrees of selective laser trabeculoplasty
Study Arms  ICMJE
  • Active Comparator: VISCO360 ab interno canaloplasty surgery
    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).
    Intervention: Device: VISCO360 ab interno canaloplasty surgery
  • Active Comparator: Selective Laser Trabeculoplasty (SLT)
    Subjects randomized to this arm will undergo the SLT procedure.
    Intervention: Device: Selective Laser Trabeculoplasty (SLT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 26, 2019)
29
Original Estimated Enrollment  ICMJE
 (submitted: October 7, 2016)
497
Actual Study Completion Date  ICMJE January 17, 2019
Actual Primary Completion Date January 17, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02928289
Other Study ID Numbers  ICMJE SIGHTVISCO-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sight Sciences, Inc.
Study Sponsor  ICMJE Sight Sciences, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sight Sciences, Inc.
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP