Glaucoma, Open-Angle
Conditions
Brief summary
The purpose of this study is to evaluate the long-term safety and effectiveness of the OMNI® Surgical System in subjects who were treated under protocol #06213
Interventions
DEVICEOMNI® Surgical System
The OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.
Sponsors
Sight Sciences, Inc.
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
• Participated in, received treatment, and completed Protocol #06213
Exclusion criteria
* Systemic disease that, in the opinion of the Investigator, would put the subject's health at risk and/or prevent completion of required study visits * Ocular pathology which, in the Investigator's judgment, would either place the subject at increased risk of complications, contraindicate washout, place the subject at risk of significant vision loss during the study period (e.g., wet age macular degeneration (AMD), corneal edema, Fuch's dystrophy, active intraocular infection or inflammation within 30 days prior to Screening Visit, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to Investigator's office for follow-up visits)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint | 12 months | Rate of occurrence of sight-threatening adverse events |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Intraocular Pressure (IOP) Between 6 and 18mmHg Inclusive. | 12 months | For cohort A: unmedicated diurnal IOP between 6 and 18 mmHg inclusive For cohort B: medicated IOP between 6 and 18 mmHg inclusive |
| Change in Intraocular Pressure (IOP) | 12 months | Mean change in IOP |
| Change in Hypotensive Medications | 12 months | Reduction in number of hypotensive medications from baseline to 36 months |
| Number of Participants With ≥20% Reduction in IOP From Baseline to 36 Months | 12 months | For subjects in cohort A : ≥20% reduction in unmedicated diurnal IOP from baseline to 36 months For subjects in cohort B: ≥20% reduction in mean medicated IOP from baseline to 36 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort A Pre-operative washout of ocular hypotensive medications with post-washout DIOP of 21-36mmHg | 66 |
| Cohort B No pre-operative washout of ocular hypotensive medications with pre-operative medicated IOP ≥18 mmHg and on 1 to 5 hypotensive medications | 4 |
| Total | 70 |
Baseline characteristics
| Characteristic | Cohort B | Cohort A | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 53 Participants | 56 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 13 Participants | 14 Participants |
| Age, Continuous | 68.0 years STANDARD_DEVIATION 14.1 | 71.6 years STANDARD_DEVIATION 7.5 | 71.4 years STANDARD_DEVIATION 7.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 22 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 44 Participants | 47 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 | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 6 Participants | 6 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 59 Participants | 63 Participants |
| Region of Enrollment United States | 4 participants | 66 participants | 70 participants |
| Sex: Female, Male Female | 2 Participants | 36 Participants | 38 Participants |
| Sex: Female, Male Male | 2 Participants | 30 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 66 | 0 / 4 |
| other Total, other adverse events | 27 / 66 | 2 / 4 |
| serious Total, serious adverse events | 1 / 66 | 0 / 4 |
Outcome results
Primary
Primary Safety Endpoint
Rate of occurrence of sight-threatening adverse events
Time frame: 12 months
Population: ITT/Safety population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A | Primary Safety Endpoint | 0 adverse event | Standard Deviation 0 |
| Cohort B | Primary Safety Endpoint | 0 adverse event | Standard Deviation 0 |
Other Pre-specified
Change in Hypotensive Medications
Reduction in number of hypotensive medications from baseline to 36 months
Time frame: 12 months
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A | Change in Hypotensive Medications | -1.2 number of medications | Standard Deviation 0.87 |
| Cohort B | Change in Hypotensive Medications | -1.0 number of medications | Standard Deviation 1 |
Other Pre-specified
Change in Intraocular Pressure (IOP)
Mean change in IOP
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A | Change in Intraocular Pressure (IOP) | -6.89 mmHg | Standard Deviation 3.42 |
| Cohort B | Change in Intraocular Pressure (IOP) | -11.00 mmHg | Standard Deviation 16.45 |
Other Pre-specified
Number of Participants With ≥20% Reduction in IOP From Baseline to 36 Months
For subjects in cohort A : ≥20% reduction in unmedicated diurnal IOP from baseline to 36 months For subjects in cohort B: ≥20% reduction in mean medicated IOP from baseline to 36 months
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A | Number of Participants With ≥20% Reduction in IOP From Baseline to 36 Months | 45 Participants |
| Cohort B | Number of Participants With ≥20% Reduction in IOP From Baseline to 36 Months | 1 Participants |
Other Pre-specified
Number of Participants With Intraocular Pressure (IOP) Between 6 and 18mmHg Inclusive.
For cohort A: unmedicated diurnal IOP between 6 and 18 mmHg inclusive For cohort B: medicated IOP between 6 and 18 mmHg inclusive
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A | Number of Participants With Intraocular Pressure (IOP) Between 6 and 18mmHg Inclusive. | 41 Participants |
| Cohort B | Number of Participants With Intraocular Pressure (IOP) Between 6 and 18mmHg Inclusive. | 2 Participants |