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Trial record 1 of 2085 for:    sight sciences
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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)

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Sight Sciences, Inc.
Sponsor:
Information provided by (Responsible Party):
Sight Sciences, Inc.
ClinicalTrials.gov Identifier:
NCT02928289
First received: October 6, 2016
Last updated: May 1, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention
Open-Angle Glaucoma Device: VISCO360 ab interno canaloplasty surgery Device: Selective Laser Trabeculoplasty (SLT)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sight Sciences, Inc.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 497
Study Start Date: November 2016
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Device: VISCO360 ab interno canaloplasty surgery
Active Comparator: Selective Laser Trabeculoplasty (SLT)
Subjects randomized to this arm will undergo the SLT procedure.
Device: Selective Laser Trabeculoplasty (SLT)

  Eligibility

Ages Eligible for Study:   22 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02928289

Contacts
Contact: Anne-Marie Ripley anne@sightsciences.com

Locations
United States, California
Coastal Vision Medical Group Not yet recruiting
Orange, California, United States, 92868
Contact: Ashley Owyang, OD    714-771-1213      
United States, Pennsylvania
Wills Eye Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Jeanne Molineaux       jmolineaux@willseye.org   
Principal Investigator: Jonathon Myers, MD         
United States, Texas
El Paso Eye Surgeons Recruiting
El Paso, Texas, United States, 79902
Contact: Axton Supnet    915-542-0279    axton.supnet2462@gmail.com   
Ophthalmology Associates Recruiting
Fort Worth, Texas, United States, 76102
Contact: Brian Flowers, MD    817-332-2020      
Sponsors and Collaborators
Sight Sciences, Inc.
  More Information

Responsible Party: Sight Sciences, Inc.
ClinicalTrials.gov Identifier: NCT02928289     History of Changes
Other Study ID Numbers: SIGHTVISCO-001
Study First Received: October 6, 2016
Last Updated: May 1, 2017

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on June 23, 2017