Safety and Effectiveness of the Sight Sciences VISCO™360 Versus SLT in Primary Open Angle Glaucoma

Not Applicable

Terminated

• Conditions: Open-Angle Glaucoma

• Registration Number: NCT02928289
• Lead Sponsor: Sight Sciences, Inc.

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

This is a randomized study comparing viscodilation with the VISCO360 device to selective laser trabeculoplasty. Subjects with mild to moderate primary open-angle glaucoma undergo IOP-lowering medication washout at baseline and at Month 12. Subjects will be followed through Month 24.

Study Timeline

• Study First Submitted: 2016-10-06
• Study First Submitted QC: 2016-10-07
• Study First Posted: 2016-10-10
• Study Start: 2017-01-23
• Primary Completion: 2019-01-17
• Study Completion: 2019-01-17
• Status Verified: 2025-08
• Results First Submitted: 2025-08-12
• Results First Submitted QC: 2025-09-04
• Last Update Submitted: 2025-09-04
• Results First Posted: 2025-09-24
• Last Update Posted: 2025-09-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Diurnal IOP at 12 Months (Measured in mm Hg)	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of Subjects Achieving a ≥ 20% Change in Mean Diurnal IOP at 12 Months	12 months	Measurement is performed at 12 months following wash-out of glaucoma medication and is the number of subjects with 12 month DIOP that is at least 20% lower than the baseline DIOP divided by the number of subjects and multiplied by 100.

Trial Locations

Locations (6)

Vold Vision; 🇺🇸 Fayetteville, Arkansas, United States

Coastal Vision Medical Group; 🇺🇸 Orange, California, United States

Dean McGee Eye Institute; 🇺🇸 Oklahoma City, Oklahoma, United States

Wills Eye Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

El Paso Eye Surgeons; 🇺🇸 El Paso, Texas, United States

Ophthalmology Associates; 🇺🇸 Fort Worth, Texas, United States