NCT02928289

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 10, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

January 23, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2019

Completed
6.7 years until next milestone

Results Posted

Study results publicly available

September 24, 2025

Completed
Last Updated

November 14, 2025

Status Verified

October 1, 2025

Enrollment Period

2 years

First QC Date

October 6, 2016

Results QC Date

August 12, 2025

Last Update Submit

October 27, 2025

Conditions

Open-Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Mean Change From Baseline in Diurnal IOP at 12 Months (Measured in mm Hg)

    The mean of the difference between the baseline DIOP and the 12 month DIOP for each subject. Measurements at baseline and 12 months are following wash-out of glaucoma medication.

    12 months

Secondary Outcomes (1)

  • Proportion of Subjects Achieving a ≥ 20% Change in Mean Diurnal IOP at 12 Months

    12 months

Study Arms (2)

VISCO360 ab interno canaloplasty surgery

ACTIVE COMPARATOR

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

Selective Laser Trabeculoplasty (SLT)

ACTIVE COMPARATOR

Subjects randomized to this arm will undergo the SLT procedure.

Device: Selective Laser Trabeculoplasty (SLT)

Interventions

VISCO360 ab interno canaloplasty surgeryDEVICE

360 degrees of viscodilation of Schlemm's canal

VISCO360 ab interno canaloplasty surgery
Selective Laser Trabeculoplasty (SLT)DEVICE

360 degrees of selective laser trabeculoplasty

Selective Laser Trabeculoplasty (SLT)

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Vold Vision

Fayetteville, Arkansas, 72704, United States

Location

Coastal Vision Medical Group

Orange, California, 92868, United States

Location

Dean McGee Eye Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

El Paso Eye Surgeons

El Paso, Texas, 79902, United States

Location

Ophthalmology Associates

Fort Worth, Texas, 76102, United States

Location

Related Publications (1)

  • 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.

    PMID: 35943114DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Results Point of Contact

Title
VP, Medical and Clinical Affairs
Organization
Sight Sciences, Inc.
jdickerson@sightsciences.com
877-266-1144

Study Officials

  • Anne-Marie Ripley

    Sight Sciences, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2016

First Posted

October 10, 2016

Study Start

January 23, 2017

Primary Completion

January 17, 2019

Study Completion

January 17, 2019

Last Updated

November 14, 2025

Results First Posted

September 24, 2025

Record last verified: 2025-10

Locations

US(6)