Open-Angle Glaucoma
Conditions
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.
Interventions
DEVICEVISCO360 ab interno canaloplasty surgery
360 degrees of viscodilation of Schlemm's canal
360 degrees of selective laser trabeculoplasty
Sponsors
Sight Sciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Twenty-nine potential subjects provided written informed consent, however only 17 met eligibility criteria and were then randomized and treated.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 7 |
| Selective Laser Trabeculoplasty (SLT) Subjects randomized to this arm will undergo the SLT procedure.
Selective Laser Trabeculoplasty (SLT): 360 degrees of selective laser trabeculoplasty | 10 |
| Total | 17 |
Baseline characteristics
| Characteristic | VISCO360 ab Interno Canaloplasty Surgery | Selective Laser Trabeculoplasty (SLT) | Total |
|---|---|---|---|
| Age, Continuous | 76.1 years STANDARD_DEVIATION 6.7 | 74.7 years STANDARD_DEVIATION 11.5 | 75.4 years STANDARD_DEVIATION 9.1 |
| Diurnal Intraocular Pressure | 25.8 mm Hg STANDARD_DEVIATION 4.3 | 25.1 mm Hg STANDARD_DEVIATION 2.5 | 25.4 mm Hg STANDARD_DEVIATION 3.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 8 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) White | 3 Participants | 8 Participants | 11 Participants |
| Region of Enrollment United States | 7 Participants | 10 Participants | 17 Participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 9 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 7 | 0 / 10 |
| other Total, other adverse events | 1 / 7 | 4 / 10 |
| serious Total, serious adverse events | 1 / 7 | 2 / 10 |
Outcome results
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.
Time frame: 12 months
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VISCO360 ab interno canaloplasty surgery | Mean Change From Baseline in Diurnal IOP at 12 Months (Measured in mm Hg) | -5.2 mm Hg | Standard Deviation 7.6 |
| Selective Laser Trabeculoplasty (SLT) | Mean Change From Baseline in Diurnal IOP at 12 Months (Measured in mm Hg) | -3.6 mm Hg | Standard Deviation 3.3 |
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.
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VISCO360 ab interno canaloplasty surgery | Proportion of Subjects Achieving a ≥ 20% Change in Mean Diurnal IOP at 12 Months | 2 Participants |
| Selective Laser Trabeculoplasty (SLT) | Proportion of Subjects Achieving a ≥ 20% Change in Mean Diurnal IOP at 12 Months | 1 Participants |