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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Subjects who had a surgical washout of ocular hypotensive medications with post-washout DIOP of 21-36mmHg and were treated with OMNI Surgical System for OAG in combination with cataract extraction at least 700 days prior to study enrollment. |
| |
| Cohort B | Subjects without a surgical washout of ocular hypotensive medications with pre-surgical medicated IOP≥18 mmHg and on 1 to 5hypotensive medications and were treated with OMNI Surgical System for OAG in combination with cataract extraction at least 700 days prior to study enrollment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OMNI® Surgical System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Endpoint | Rate of occurrence of sight-threatening adverse events | 12 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Intraocular Pressure (IOP) | Mean change in IOP | 12 months |
| Change in Hypotensive Medications | Reduction in number of hypotensive medications from baseline to 36 months |
Inclusion Criteria:
• Participated in, received treatment, and completed Protocol #06213
Exclusion Criteria:
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Participants who received treatment and completed Protocol #06213
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grene Vision Group | Wichita | Kansas | 62708 | United States | ||
| Oklahoma Eye Surgeons |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A | Subjects who had a pre-surgical washout of ocular hypotensive medications with post-washout DIOP of 21-36mmHg and were treated with OMNI Surgical System for OAG in combination with cataract extraction at least 700 days prior to study enrollment. |
| FG001 | Cohort B | Subjects without a pre-surgical washout of ocular hypotensive medications with pre-surgical medicated IOP≥18 mmHg and on 1 to 5 hypotensive medications and were treated with OMNI Surgical System for OAG in combination with cataract extraction at least 700 days prior to study enrollment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The Intent-to-Treat (ITT) analysis population included all subjects who were enrolled and treated, regardless of whether or not they had a protocol deviation
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A | Pre-operative washout of ocular hypotensive medications with post-washout DIOP of 21-36mmHg |
| BG001 | Cohort B | No pre-operative washout of ocular hypotensive medications with pre-operative medicated IOP ≥18 mmHg and on 1 to 5 hypotensive medications |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Primary Safety Endpoint | Rate of occurrence of sight-threatening adverse events | ITT/Safety population | Posted | Mean | Standard Deviation | adverse event | 12 months |
|
|
36 months
Adverse events were collected from the time of the study procedure (retrospective data) through the 36-month visit.
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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 | Cohort A | Pre-operative washout of ocular hypotensive medications. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse events | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Fell and cracked hip. Surgery required. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular adverse events | Eye disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, Medical and Clinical Affairs | Sight Sciences, Inc. | 1-877-266-1144 | jdickerson@sightsciences.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 18, 2022 | Jan 21, 2025 | Prot_SAP_000.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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|
| 12 months |
| 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 | 12 months |
| 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 | 12 months |
| Oklahoma City |
| Oklahoma |
| 73112 |
| United States |
| Northern Ophthalmics | Jenkintown | Pennsylvania | 19406 | United States |
| El Paso Eye Surgeons | El Paso | Texas | 79902 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Age at consent | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Other Pre-specified | Change in Intraocular Pressure (IOP) | Mean change in IOP | Posted | Mean | Standard Deviation | mmHg | 12 months |
|
|
|
| Other Pre-specified | Change in Hypotensive Medications | Reduction in number of hypotensive medications from baseline to 36 months | Intent to treat | Posted | Mean | Standard Deviation | number of medications | 12 months |
|
|
|
| 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 | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 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 | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 66 |
| 1 |
| 66 |
| 27 |
| 66 |
| EG001 | Cohort B | No pre-operative washout of ocular hypotensive medications. | 0 | 4 | 0 | 4 | 2 | 4 |
|
The institution or PI will submit a copy of any proposed publication/disclosure to Sponsor, at least sixty (60) days prior to submission. Sponsor may request changes or other measures to ensure the information is fairly stated. At Sponsor's request the Institution and/or the PI shall not publish/disclose information related to the Study. If Sponsor indicates that such publication or disclosure contains Confidential Information, the Institution and PI agree to remove such Confidential Information