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Poor enrollment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Selective Laser Trabeculoplasty (SLT) | Active Comparator | Subjects randomized to this arm will undergo the SLT procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VISCO360 ab interno canaloplasty surgery | Device | 360 degrees of viscodilation of Schlemm's canal |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Achieving a ≥ 20% Change in Mean Diurnal IOP at 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne-Marie Ripley | Sight Sciences, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vold Vision | Fayetteville | Arkansas | 72704 | United States | ||
| Coastal Vision Medical Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35943114 | Derived | 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. |
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Subjects provided informed consent at the Screening visit and if the screening eligibility criteria were met, underwent a washout of their intraocular pressure (IOP) lowering medication (generally 4 weeks) before returning for the baseline visit where diurnal IOP was measured. Subjects meeting the diurnall IOP criteria at the baseline visit were than randomized and treated.
Twenty-nine potential subjects provided written informed consent, however only 17 met eligibility criteria and were then randomized and treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). VISCO360 ab interno canaloplasty surgery: 360 degrees of viscodilation of Schlemm's canal |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 1, 2017 | Aug 12, 2025 |
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| Selective Laser Trabeculoplasty (SLT) | Device | 360 degrees of selective laser trabeculoplasty |
|
| Orange |
| California |
| 92868 |
| United States |
| Dean McGee Eye Institute | Oklahoma City | Oklahoma | 73104 | United States |
| Wills Eye Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| El Paso Eye Surgeons | El Paso | Texas | 79902 | United States |
| Ophthalmology Associates | Fort Worth | Texas | 76102 | United States |
| Selective Laser Trabeculoplasty (SLT) |
Subjects randomized to this arm will undergo the SLT procedure. Selective Laser Trabeculoplasty (SLT): 360 degrees of selective laser trabeculoplasty |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). VISCO360 ab interno canaloplasty surgery: 360 degrees of viscodilation of Schlemm's canal |
| BG001 | Selective Laser Trabeculoplasty (SLT) | Subjects randomized to this arm will undergo the SLT procedure. Selective Laser Trabeculoplasty (SLT): 360 degrees of selective laser trabeculoplasty |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Diurnal Intraocular Pressure | Mean of the IOP taken using Goldmann tonometry at 3 diurnal timepoints and measured in mm Hg | Mean | Standard Deviation | mm Hg |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Only seven (7) subjects, 3 in the VISCO360 group, and 4 in the SLT group had completed the Month 12 endpoint visit at the time the study was terminated for poor enrollment. One of the 4 subjects in the SLT group underwent a secondary glaucoma procedure (gel stent) at Day 266 so the 12 month DIOP was imputed as the Baseline DIOP (per the protocol analysis plan). | Posted | Mean | Standard Deviation | mm Hg | 12 months |
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| Secondary | Proportion of Subjects Achieving a ≥ 20% Change in Mean Diurnal IOP at 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. | Only seven (7) subjects, 3 in the VISCO360 group, and 4 in the SLT group had completed the Month 12 endpoint visit at the time the study was terminated for poor enrollment. | Posted | Count of Participants | Participants | 12 months |
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18 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). VISCO360 ab interno canaloplasty surgery: 360 degrees of viscodilation of Schlemm's canal | 1 | 7 | 1 | 7 | 1 | 7 |
| EG001 | Selective Laser Trabeculoplasty (SLT) | Subjects randomized to this arm will undergo the SLT procedure. Selective Laser Trabeculoplasty (SLT): 360 degrees of selective laser trabeculoplasty | 0 | 10 | 2 | 10 | 4 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular adverse event | Eye disorders | Non-systematic Assessment | IOP increase requiring intervention with SLT |
| |
| non-ocular | Cardiac disorders | Non-systematic Assessment | Second-Degree Atrioventricular Block |
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| non-ocular | Cardiac disorders | Non-systematic Assessment | transient ischemic attach |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular adverse events | Eye disorders | Non-systematic Assessment | IOP increase >= 10 mmHg vs. baseline IOP occurring at any visit |
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| ocular adverse event | Eye disorders | Non-systematic Assessment | Need for secondary surgical intervention |
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| non-ocular adverse event | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Bronchitis |
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| non ocular adverse event | General disorders | Non-systematic Assessment | Headaches |
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| ocular adverse event | Eye disorders | Non-systematic Assessment | IOP increase requiring management with systemic medication or with surgical intervention |
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| ocular adverse event | Eye disorders | Non-systematic Assessment | dryness |
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| non ocular adverse event | General disorders | Non-systematic Assessment | Worsening vertigo |
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After Sponsor's publication of trial results, the Institution and Principal Investigator may publish the results of the Study generated by the Institution, subject to the obligations of the CTA, and prior approval of Sponsor in writing. The Institution shall furnish Sponsor with a written copy of any proposed publication or disclosure at least 60 days prior to submission for publication or disclosure. Sponsor may request changes or other measures to ensure the information is fairly stated.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, Medical and Clinical Affairs | Sight Sciences, Inc. | 877-266-1144 | jdickerson@sightsciences.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 22, 2016 | Aug 12, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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