Trial Outcomes & Findings for A Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System (NCT NCT05044793)

NCT ID: NCT05044793

Last Updated: 2025-01-22

Results Overview

Rate of occurrence of sight-threatening adverse events

• Recruitment status: COMPLETED
• Target enrollment: 70 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2025-01-22

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	66	4
Overall Study COMPLETED	66	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System

Baseline characteristics by cohort

Measure	Cohort A n=66 Participants Pre-operative washout of ocular hypotensive medications with post-washout DIOP of 21-36mmHg	Cohort B n=4 Participants No pre-operative washout of ocular hypotensive medications with pre-operative medicated IOP ≥18 mmHg and on 1 to 5 hypotensive medications	Total n=70 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	1 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	53 Participants n=5 Participants	3 Participants n=7 Participants	56 Participants n=5 Participants
Age, Continuous	71.6 years STANDARD_DEVIATION 7.5 • n=5 Participants	68.0 years STANDARD_DEVIATION 14.1 • n=7 Participants	71.4 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	2 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	2 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	22 Participants n=5 Participants	1 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	44 Participants n=5 Participants	3 Participants n=7 Participants	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	59 Participants n=5 Participants	4 Participants n=7 Participants	63 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	66 participants n=5 Participants	4 participants n=7 Participants	70 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: ITT/Safety population

Rate of occurrence of sight-threatening adverse events

Outcome measures

Measure	Cohort A n=66 Participants Pre-operative washout of ocular hypotensive medications.	Cohort B n=4 Participants No pre-operative washout of ocular hypotensive medications.
Primary Safety Endpoint	0 adverse event Standard Deviation 0	0 adverse event Standard Deviation 0

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Mean change in IOP

Outcome measures

Measure	Cohort A n=66 Participants Pre-operative washout of ocular hypotensive medications.	Cohort B n=4 Participants No pre-operative washout of ocular hypotensive medications.
Change in Intraocular Pressure (IOP)	-6.89 mmHg Standard Deviation 3.42	-11.00 mmHg Standard Deviation 16.45

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: Intent to treat

Reduction in number of hypotensive medications from baseline to 36 months

Outcome measures

Measure	Cohort A n=66 Participants Pre-operative washout of ocular hypotensive medications.	Cohort B n=4 Participants No pre-operative washout of ocular hypotensive medications.
Change in Hypotensive Medications	-1.2 number of medications Standard Deviation 0.87	-1.0 number of medications Standard Deviation 1.00

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Measure	Cohort A n=66 Participants Pre-operative washout of ocular hypotensive medications.	Cohort B n=4 Participants No pre-operative washout of ocular hypotensive medications.
Number of Participants With ≥20% Reduction in IOP From Baseline to 36 Months	45 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Measure	Cohort A n=66 Participants Pre-operative washout of ocular hypotensive medications.	Cohort B n=4 Participants No pre-operative washout of ocular hypotensive medications.
Number of Participants With Intraocular Pressure (IOP) Between 6 and 18mmHg Inclusive.	41 Participants	2 Participants

Adverse Events

Cohort A

Serious events: 1 serious events

Other events: 27 other events

Deaths: 0 deaths

Cohort B

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cohort A n=66 participants at risk Pre-operative washout of ocular hypotensive medications.	Cohort B n=4 participants at risk No pre-operative washout of ocular hypotensive medications.
Musculoskeletal and connective tissue disorders Adverse events	1.5% 1/66 • Number of events 1 • 36 months Adverse events were collected from the time of the study procedure (retrospective data) through the 36-month visit.	0.00% 0/4 • 36 months Adverse events were collected from the time of the study procedure (retrospective data) through the 36-month visit.

Other adverse events

Measure	Cohort A n=66 participants at risk Pre-operative washout of ocular hypotensive medications.	Cohort B n=4 participants at risk No pre-operative washout of ocular hypotensive medications.
Eye disorders Ocular adverse events	40.9% 27/66 • Number of events 35 • 36 months Adverse events were collected from the time of the study procedure (retrospective data) through the 36-month visit.	50.0% 2/4 • Number of events 2 • 36 months Adverse events were collected from the time of the study procedure (retrospective data) through the 36-month visit.

Additional Information

VP, Medical and Clinical Affairs

Sight Sciences, Inc.

Phone: 1-877-266-1144

Email: jdickerson@sightsciences.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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
• Publication restrictions are in place

Restriction type: OTHER