Trial Outcomes & Findings for An Observational Multicenter Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System In Pseudophakic Eyes With Primary Open Angle Glaucoma (ORION 2.0) (NCT NCT04872348)
NCT ID: NCT04872348
Last Updated: 2025-05-22
Results Overview
Percent change in unmedicated diurnal intraocular pressure (DIOP/washout) or medicated intraocular pressure (IOP/no washout) compared to baseline.
Recruitment status
COMPLETED
Target enrollment
28 participants
Primary outcome timeframe
18 months
Results posted on
2025-05-22
Participant Flow
Participant milestones
| Measure |
Washout
Eyes receiving OMNI intervention after medication washout.
|
No Washout
Eyes receiving OMNI intervention without medication washout
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
10
|
|
Overall Study
COMPLETED
|
18
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Observational Multicenter Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System In Pseudophakic Eyes With Primary Open Angle Glaucoma (ORION 2.0)
Baseline characteristics by cohort
| Measure |
Washout
n=18 Participants
Eyes receiving OMNI intervention after medication washout.
|
No Washout
n=10 Participants
Eyes receiving OMNI intervention without medication washout
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.0 years
STANDARD_DEVIATION 8.2 • n=93 Participants
|
76.0 years
STANDARD_DEVIATION 4.7 • n=4 Participants
|
75.4 years
STANDARD_DEVIATION 7.0 • n=27 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=93 Participants
|
10 participants
n=4 Participants
|
28 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Intent To Treat
Percent change in unmedicated diurnal intraocular pressure (DIOP/washout) or medicated intraocular pressure (IOP/no washout) compared to baseline.
Outcome measures
| Measure |
Washout
n=13 Participants
Eyes receiving OMNI intervention after medication washout.
|
No Washout
n=8 Participants
Eyes receiving OMNI intervention without medication washout
|
|---|---|---|
|
Change in Intraocular Pressure (IOP)
|
38.2 percent change
Standard Deviation 15.53
|
30.1 percent change
Standard Deviation 24.14
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Intent To Treat
Mean change in the number of ocular hypotensive medications compared to baseline.
Outcome measures
| Measure |
Washout
n=15 Participants
Eyes receiving OMNI intervention after medication washout.
|
No Washout
n=8 Participants
Eyes receiving OMNI intervention without medication washout
|
|---|---|---|
|
Change in Number of Medications
|
-1.13 number of medications
Standard Deviation 1.06
|
-0.13 number of medications
Standard Deviation 1.25
|
Adverse Events
Washout
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
No Washout
Serious events: 1 serious events
Other events: 7 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Washout
n=18 participants at risk
Eyes receiving OMNI intervention after medication washout.
|
No Washout
n=10 participants at risk
Eyes receiving OMNI intervention without medication washout
|
|---|---|---|
|
General disorders
Death
|
0.00%
0/18 • 24 months
|
10.0%
1/10 • Number of events 1 • 24 months
|
Other adverse events
| Measure |
Washout
n=18 participants at risk
Eyes receiving OMNI intervention after medication washout.
|
No Washout
n=10 participants at risk
Eyes receiving OMNI intervention without medication washout
|
|---|---|---|
|
Eye disorders
IOP increase above baseline at 1mont or greater
|
5.6%
1/18 • Number of events 1 • 24 months
|
10.0%
1/10 • Number of events 2 • 24 months
|
|
Eye disorders
Layered Hyphema
|
0.00%
0/18 • 24 months
|
10.0%
1/10 • Number of events 1 • 24 months
|
|
Eye disorders
Secondary Surgical Intervention
|
5.6%
1/18 • Number of events 1 • 24 months
|
0.00%
0/10 • 24 months
|
|
Eye disorders
Corneal edema after 1 week
|
0.00%
0/18 • 24 months
|
10.0%
1/10 • Number of events 1 • 24 months
|
|
Eye disorders
IOL dislocation and/or damage
|
0.00%
0/18 • 24 months
|
10.0%
1/10 • Number of events 1 • 24 months
|
|
Eye disorders
Posterior capsular opacification
|
5.6%
1/18 • Number of events 1 • 24 months
|
20.0%
2/10 • Number of events 2 • 24 months
|
|
Eye disorders
Iridodialysis or significant iris damage
|
0.00%
0/18 • 24 months
|
10.0%
1/10 • Number of events 1 • 24 months
|
|
Eye disorders
Conjunctival hyperemia
|
5.6%
1/18 • Number of events 1 • 24 months
|
0.00%
0/10 • 24 months
|
|
Eye disorders
Corneal epithelial microcysts
|
0.00%
0/18 • 24 months
|
10.0%
1/10 • Number of events 1 • 24 months
|
|
General disorders
Dizziness
|
0.00%
0/18 • 24 months
|
10.0%
1/10 • Number of events 1 • 24 months
|
|
General disorders
Dry Eye
|
11.1%
2/18 • Number of events 2 • 24 months
|
10.0%
1/10 • Number of events 1 • 24 months
|
|
Eye disorders
Eye pain
|
0.00%
0/18 • 24 months
|
10.0%
1/10 • Number of events 1 • 24 months
|
|
Eye disorders
Glaucoma
|
0.00%
0/18 • 24 months
|
10.0%
1/10 • Number of events 1 • 24 months
|
|
General disorders
Headache
|
0.00%
0/18 • 24 months
|
10.0%
1/10 • Number of events 1 • 24 months
|
|
Eye disorders
Intraocular pressure increased
|
0.00%
0/18 • 24 months
|
10.0%
1/10 • Number of events 1 • 24 months
|
|
Eye disorders
Iridocele
|
5.6%
1/18 • Number of events 1 • 24 months
|
0.00%
0/10 • 24 months
|
|
Eye disorders
Iris adhesions
|
5.6%
1/18 • Number of events 1 • 24 months
|
0.00%
0/10 • 24 months
|
|
Eye disorders
Iris atrophy
|
5.6%
1/18 • Number of events 1 • 24 months
|
0.00%
0/10 • 24 months
|
|
Eye disorders
Iris transillumination defect
|
16.7%
3/18 • Number of events 3 • 24 months
|
0.00%
0/10 • 24 months
|
|
General disorders
Nausea
|
0.00%
0/18 • 24 months
|
10.0%
1/10 • Number of events 1 • 24 months
|
|
Eye disorders
Pigment dispersion syndrome
|
11.1%
2/18 • Number of events 2 • 24 months
|
0.00%
0/10 • 24 months
|
|
Eye disorders
Punctate keratitis
|
5.6%
1/18 • Number of events 1 • 24 months
|
0.00%
0/10 • 24 months
|
|
Eye disorders
Pupillary reflex impaired
|
0.00%
0/18 • 24 months
|
10.0%
1/10 • Number of events 1 • 24 months
|
|
Eye disorders
Retinal drusen
|
5.6%
1/18 • Number of events 1 • 24 months
|
0.00%
0/10 • 24 months
|
|
General disorders
Sinus pain
|
11.1%
2/18 • Number of events 2 • 24 months
|
0.00%
0/10 • 24 months
|
Additional Information
VP, Medical and Clinical Affairs
Sight Sciences, Inc.
Phone: 1-877-266-1144
Email: [email protected]
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