Open Angle Glaucoma
Conditions
Brief summary
This study will prospectively assess the clinical effect of ab-interno transluminal viscoelastic delivery and trabeculotomy performed using the OMNI Surgical System in combination with Cataract Extraction on intraocular pressure (IOP) and the use of IOP-lowering medications in patients with mild-moderate open angle glaucoma (OAG).
Detailed description
This prospective, multicenter, single-arm, post-market clinical study will evaluate the impact of ab-interno transluminal viscoelastic delivery and trabeculotomy using OMNI Surgical System in conjunction with cataract surgery on IOP and the use of hypotensive medications in patients with mild to moderate open angle glaucoma.
Interventions
DEVICETransluminal viscoelastic delivery and trabeculotomy
Ab-interno transluminal viscoelastic delivery and trabeculotomy using OMNI Surgical System
Sponsors
Sight Sciences, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Only one eye of each subject was eligible (the study eye), and all ocular criteria listed below applied to the study eye. 1. Male or female subjects, 22 years or older 2. Visually significant cataract 3. Diagnosed with mild to moderate open-angle glaucoma (e.g., primary open-angle glaucoma, pigmentary glaucoma, pseudoexfoliative glaucoma) as documented in subjects' medical record per ICD-10 guidelines 4. At screening, a medicated IOP ≤ 33 mmHg and on 1-4 IOP-lowering medications1 with a stable medication regimen for two months prior to screening visit 5. At baseline, unmedicated diurnal IOP 21-36 mmHg and IOP at least 3 mmHg higher than screening IOP 6. Scheduled for cataract extraction followed by ab- interno transluminal viscoelastic delivery and trabeculotomy using the OMNI Surgical System 7. Shaffer grade of ≥ 3 in all four quadrants 8. Potential of good best corrected visual acuity post cataract extraction, in the Investigator's judgment 9. Able and willing to comply with the protocol, including all follow-up visits. 10. Understood and signed the informed consent
Exclusion criteria
All criteria listed below applied to the study eye; both eyes of a single subject need not have been eligible for the study. 1. Any of the following prior treatments for glaucoma: * Laser trabeculoplasty ≤ 3 months prior to baseline * Implanted with iStent, CyPass, Xen, Express, glaucoma draining device/valve, or Hydrus Device * Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy, ECP or CPC 2. Normal tension glaucoma 3. Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma 4. Severe glaucoma as documented in subjects' medical record per ICD-10 guidelines 5. Use of oral hypotensive medication treatment for glaucoma 6. In the Investigator's judgement, predisposed to significant risk because of washout of ocular hypotensive medications 7. Ocular pathology or medical condition which, in the Investigator's judgment, would either place the subject at increased risk of complications, contraindicate surgery, place the subject at risk of significant vision loss during the study period (e.g., wet AMD, corneal edema, Fuch's dystrophy, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to Investigator's office for follow-up visits) 8. Participation (≤ 30 days prior to baseline) in an interventional trial which could have a potential effect on the study outcome, as determined by the study investigator 9. Women of childbearing potential if they are currently pregnant or intend to become pregnant during the study period; are breast-feeding; or are not in agreement to use adequate birth control methods to prevent pregnancy throughout the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Unmedicated Diurnal IOP | 12 months | Change in mean unmedicated diurnal IOP from baseline to 12 months |
| Change in Mean Number of IOP-Lowering Medications | 12 months | Reduction in mean number of IOP-lowering medications from screening to 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Eyes With a ≥20% Reduction in Unmedicated DIOP | 12 months | First Secondary Effectiveness endpoint/Percent of eyes with a ≥20% reduction in unmedicated DIOP at 12 months |
| Percent of Eyes With Unmedicated Diurnal IOP Between 6 and 18 mmHg Inclusive at 12 Months | 12 months | Second Secondary Effectiveness Endpoint: Unmedicated DIOP ≥ 6 mmHg and ≤ 18 mmHg at 12 Months/Percent of eyes with unmedicated DIOP between 6 and 18 mmHg inclusive at 12 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OMNI® Surgical System Eligible subjects had cataract and mild-moderate OAG with intraocular pressure (IOP) ≤33 mmHg on 1 to 4 hypotensive medications at Screening and Cataract extraction followed by ab-interno transluminal viscoelastic delivery and trabeculotomy using the OMNI Surgical System | 149 |
| Total | 149 |
Baseline characteristics
| Characteristic | OMNI® Surgical System |
|---|---|
| Age, Continuous ITT/Safety Population | 68.3 Years STANDARD_DEVIATION 8.5 |
| Age, Continuous mITT | 68.6 Years STANDARD_DEVIATION 8.3 |
| Age, Continuous Per Protocol Population | 68.8 Years STANDARD_DEVIATION 8 |
| Ethnicity (NIH/OMB) ITT/Safety Population Hispanic or Latino | 41 Participants |
| Ethnicity (NIH/OMB) ITT/Safety Population Not Hispanic or Latino | 108 Participants |
| Ethnicity (NIH/OMB) ITT/Safety Population Unknown or Not Reported | 0 Participants |
| Ethnicity (NIH/OMB) mITT Hispanic or Latino | 38 Participants |
| Ethnicity (NIH/OMB) mITT Not Hispanic or Latino | 103 Participants |
| Ethnicity (NIH/OMB) mITT Unknown or Not Reported | 0 Participants |
| Ethnicity (NIH/OMB) Per Protocol Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Per Protocol Not Hispanic or Latino | 90 Participants |
| Ethnicity (NIH/OMB) Per Protocol Unknown or Not Reported | 0 Participants |
| Glaucoma Status ITT/Safety Population Pigmentary | 1 Participants |
| Glaucoma Status ITT/Safety Population Primary Open Angle Glaucoma | 139 Participants |
| Glaucoma Status ITT/Safety Population Pseudoexfoliative | 9 Participants |
| Glaucoma Status mITT Pigmentary | 1 Participants |
| Glaucoma Status mITT Primary Open Angle Glaucoma | 131 Participants |
| Glaucoma Status mITT Pseudoexfoliative | 9 Participants |
| Glaucoma Status Per Protocol Population Pigmentary | 1 Participants |
| Glaucoma Status Per Protocol Population Primary Open Angle Glaucoma | 113 Participants |
| Glaucoma Status Per Protocol Population Pseudoexfoliative | 6 Participants |
| Race (NIH/OMB) ITT/Safety Population American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) ITT/Safety Population Asian | 2 Participants |
| Race (NIH/OMB) ITT/Safety Population Black or African American | 24 Participants |
| Race (NIH/OMB) ITT/Safety Population More than one race | 0 Participants |
| Race (NIH/OMB) ITT/Safety Population Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) ITT/Safety Population Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) ITT/Safety Population White | 122 Participants |
| Race (NIH/OMB) mITT American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) mITT Asian | 2 Participants |
| Race (NIH/OMB) mITT Black or African American | 23 Participants |
| Race (NIH/OMB) mITT More than one race | 0 Participants |
| Race (NIH/OMB) mITT Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) mITT Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) mITT White | 115 Participants |
| Race (NIH/OMB) Per Protocol American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Per Protocol Asian | 0 Participants |
| Race (NIH/OMB) Per Protocol Black or African American | 19 Participants |
| Race (NIH/OMB) Per Protocol More than one race | 0 Participants |
| Race (NIH/OMB) Per Protocol Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Per Protocol Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Per Protocol White | 100 Participants |
| Region of Enrollment United States | 149 Participants |
| Sex: Female, Male ITT/Safety Population Female | 89 Participants |
| Sex: Female, Male ITT/Safety Population Male | 60 Participants |
| Sex: Female, Male mITT Female | 85 Participants |
| Sex: Female, Male mITT Male | 56 Participants |
| Sex: Female, Male Per Protocol Population Female | 73 Participants |
| Sex: Female, Male Per Protocol Population Male | 47 Participants |
| Study Eye ITT/Safety Population OD | 74 Participants |
| Study Eye ITT/Safety Population OS | 75 Participants |
| Study Eye mITT OD | 70 Participants |
| Study Eye mITT OS | 71 Participants |
| Study Eye Per Protocol Population OD | 58 Participants |
| Study Eye Per Protocol Population OS | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 34 / 149 |
| other Total, other adverse events | 34 / 149 |
| serious Total, serious adverse events | 2 / 149 |
Outcome results
Primary
Change in Mean Number of IOP-Lowering Medications
Reduction in mean number of IOP-lowering medications from screening to 12 months
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Per Protocol Population | Change in Mean Number of IOP-Lowering Medications | 1.43 medications | Standard Deviation 1.14 |
Primary
Change in Mean Unmedicated Diurnal IOP
Change in mean unmedicated diurnal IOP from baseline to 12 months
Time frame: 12 months
Population: The Per Protocol (PP) analysis population was a subset of the mITT population and included all subjects who were on least one ocular hypotensive medication at screening and had uneventful cataract extraction followed by ab-interno transluminal viscoelastic delivery and trabeculotomy, 12 month IOP and medication data, and had no clinically significant protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Per Protocol Population | Change in Mean Unmedicated Diurnal IOP | 7.98 mm Hg | Standard Deviation 4.21 |
Secondary
Percent of Eyes With a ≥20% Reduction in Unmedicated DIOP
First Secondary Effectiveness endpoint/Percent of eyes with a ≥20% reduction in unmedicated DIOP at 12 months
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Per Protocol Population | Percent of Eyes With a ≥20% Reduction in Unmedicated DIOP | 84.2 percentage of eyes |
| mITT | Percent of Eyes With a ≥20% Reduction in Unmedicated DIOP | 75.9 percentage of eyes |
Secondary
Percent of Eyes With Unmedicated Diurnal IOP Between 6 and 18 mmHg Inclusive at 12 Months
Second Secondary Effectiveness Endpoint: Unmedicated DIOP ≥ 6 mmHg and ≤ 18 mmHg at 12 Months/Percent of eyes with unmedicated DIOP between 6 and 18 mmHg inclusive at 12 months
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Per Protocol Population | Percent of Eyes With Unmedicated Diurnal IOP Between 6 and 18 mmHg Inclusive at 12 Months | 77.5 percentage of eyes |
| mITT | Percent of Eyes With Unmedicated Diurnal IOP Between 6 and 18 mmHg Inclusive at 12 Months | 70.9 percentage of eyes |