Trial Outcomes & Findings for Safety and Effectiveness of the Sight Sciences VISCO™360 Versus SLT in Primary Open Angle Glaucoma (NCT NCT02928289)
NCT ID: NCT02928289
Last Updated: 2025-11-14
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
12 months
Results posted on
2025-11-14
Participant Flow
Twenty-nine potential subjects provided written informed consent, however only 17 met eligibility criteria and were then randomized and treated.
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.
Participant milestones
| Measure |
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
|
Selective Laser Trabeculoplasty (SLT)
Subjects randomized to this arm will undergo the SLT procedure.
Selective Laser Trabeculoplasty (SLT): 360 degrees of selective laser trabeculoplasty
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
10
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Effectiveness of the Sight Sciences VISCO™360 Versus SLT in Primary Open Angle Glaucoma
Baseline characteristics by cohort
| Measure |
VISCO360 ab Interno Canaloplasty Surgery
n=7 Participants
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
|
Selective Laser Trabeculoplasty (SLT)
n=10 Participants
Subjects randomized to this arm will undergo the SLT procedure.
Selective Laser Trabeculoplasty (SLT): 360 degrees of selective laser trabeculoplasty
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
76.1 years
STANDARD_DEVIATION 6.7 • n=10 Participants
|
74.7 years
STANDARD_DEVIATION 11.5 • n=10 Participants
|
75.4 years
STANDARD_DEVIATION 9.1 • n=20 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
9 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
8 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
5 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=10 Participants
|
8 Participants
n=10 Participants
|
12 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=10 Participants
|
8 Participants
n=10 Participants
|
11 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
5 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
17 Participants
n=20 Participants
|
|
Diurnal Intraocular Pressure
|
25.8 mm Hg
STANDARD_DEVIATION 4.3 • n=10 Participants
|
25.1 mm Hg
STANDARD_DEVIATION 2.5 • n=10 Participants
|
25.4 mm Hg
STANDARD_DEVIATION 3.2 • n=20 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 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).
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.
Outcome measures
| Measure |
Selective Laser Trabeculoplasty (SLT)
n=4 Participants
Subjects randomized to this arm will undergo the SLT procedure.
Selective Laser Trabeculoplasty (SLT): 360 degrees of selective laser trabeculoplasty
|
VISCO360 ab interno canaloplasty surgery
n=3 Participants
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
|
|---|---|---|
|
Mean Change From Baseline in Diurnal IOP at 12 Months (Measured in mm Hg)
|
-3.6 mm Hg
Standard Deviation 3.3
|
-5.2 mm Hg
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Selective Laser Trabeculoplasty (SLT)
n=4 Participants
Subjects randomized to this arm will undergo the SLT procedure.
Selective Laser Trabeculoplasty (SLT): 360 degrees of selective laser trabeculoplasty
|
VISCO360 ab interno canaloplasty surgery
n=3 Participants
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
|
|---|---|---|
|
Proportion of Subjects Achieving a ≥ 20% Change in Mean Diurnal IOP at 12 Months
|
1 Participants
|
2 Participants
|
Adverse Events
VISCO360 ab interno canaloplasty surgery
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Selective Laser Trabeculoplasty (SLT)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VISCO360 ab interno canaloplasty surgery
n=7 participants at risk
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
|
Selective Laser Trabeculoplasty (SLT)
n=10 participants at risk
Subjects randomized to this arm will undergo the SLT procedure.
Selective Laser Trabeculoplasty (SLT): 360 degrees of selective laser trabeculoplasty
|
|---|---|---|
|
Eye disorders
Ocular adverse event
|
0.00%
0/7 • 18 months
|
10.0%
1/10 • Number of events 1 • 18 months
|
|
Cardiac disorders
non-ocular
|
0.00%
0/7 • 18 months
|
10.0%
1/10 • Number of events 1 • 18 months
|
Other adverse events
| Measure |
VISCO360 ab interno canaloplasty surgery
n=7 participants at risk
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
|
Selective Laser Trabeculoplasty (SLT)
n=10 participants at risk
Subjects randomized to this arm will undergo the SLT procedure.
Selective Laser Trabeculoplasty (SLT): 360 degrees of selective laser trabeculoplasty
|
|---|---|---|
|
Eye disorders
Ocular adverse events
|
14.3%
1/7 • Number of events 1 • 18 months
|
0.00%
0/10 • 18 months
|
|
Eye disorders
ocular adverse event
|
0.00%
0/7 • 18 months
|
10.0%
1/10 • Number of events 1 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
non-ocular adverse event
|
0.00%
0/7 • 18 months
|
10.0%
1/10 • Number of events 1 • 18 months
|
|
General disorders
non ocular adverse event
|
0.00%
0/7 • 18 months
|
10.0%
1/10 • Number of events 1 • 18 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER