Trial Outcomes & Findings for A Post-market Study Of Use Of The OMNI® Surgical System In Open Angle Glaucoma (NCT NCT04616573)

Last Updated: 2022-12-01

Results Overview

The trial was terminated early after randomization and treatment of one subject who was exited from the study after 1 week of follow up. No meaningful conclusions or results were obtained due to early termination after the treatment of one subject.

Recruitment status

TERMINATED

Study phase

Target enrollment

1 participants

Primary outcome timeframe

1 week

Results posted on

2022-12-01

Participant Flow

Participant milestones

Participant milestones
Measure	Ab-interno Transluminal Viscoelastic Delivery With Trabeculotomy Using OMNI Surgical System OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System	Ab-interno Transluminal Viscoelastic Delivery Using OMNI Surgical System OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System	iStent Inject Implantation iStent inject: Trabecular meshwork implantation
Overall Study STARTED	1	0	0
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Post-market Study Of Use Of The OMNI® Surgical System In Open Angle Glaucoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ab-interno Transluminal Viscoelastic Delivery With Trabeculotomy Using OMNI Surgical System n=1 Participants OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System	Ab-interno Transluminal Viscoelastic Delivery Using OMNI Surgical System OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System	iStent Inject Implantation iStent inject: Trabecular meshwork implantation	Total n=1 Participants Total of all reporting groups
Age, Continuous	66 years n=5 Participants	—	—	66 years n=4 Participants
Sex/Gender, Customized Male	1 Participants n=5 Participants	—	—	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	—	—	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	—	—	1 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: 1 week

Population: No subjects were analyzed is for the 2 arms that did not have any subjects treated in the study.

Outcome measures

Outcome measures
Measure	Ab-interno Transluminal Viscoelastic Delivery With Trabeculotomy Using OMNI Surgical System n=1 Participants OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System	Ab-interno Transluminal Viscoelastic Delivery Using OMNI Surgical System OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System	iStent Inject Implantation iStent inject: Trabecular meshwork implantation
Change in Unmedicated Diurnal Intraocular Pressure (DIOP)	13.3 mmHg	—	—

SECONDARY outcome

Timeframe: 1 week

Population: The number analyzed is zero for the 2 arms of the study that did not treat any subjects/Eyes

Outcome measures

Outcome measures
Measure	Ab-interno Transluminal Viscoelastic Delivery With Trabeculotomy Using OMNI Surgical System n=1 Eyes OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System	Ab-interno Transluminal Viscoelastic Delivery Using OMNI Surgical System OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System	iStent Inject Implantation iStent inject: Trabecular meshwork implantation
Eyes With a ≥ 20% Decrease in Unmedicated Mean Diurnal Intraocular Pressure (DIOP) From Baseline	1 Eyes	—	—

SECONDARY outcome

Timeframe: 1 week

Population: The number analyzed is zero for 2 arms in the study which had no subjects treated

Outcome measures

Outcome measures
Measure	Ab-interno Transluminal Viscoelastic Delivery With Trabeculotomy Using OMNI Surgical System n=1 Eyes OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System	Ab-interno Transluminal Viscoelastic Delivery Using OMNI Surgical System OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System	iStent Inject Implantation iStent inject: Trabecular meshwork implantation
Eyes With Unmedicated Diurnal Intraocular Pressure (DIOP) Between 6 and 18 mmHg Inclusive	1 Eyes	—	—

SECONDARY outcome

Timeframe: 1 week

Population: The number analyzed is zero for 2 arms in the study that did not have any treatments

Outcome measures

Outcome measures
Measure	Ab-interno Transluminal Viscoelastic Delivery With Trabeculotomy Using OMNI Surgical System n=1 Participants OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System	Ab-interno Transluminal Viscoelastic Delivery Using OMNI Surgical System OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System	iStent Inject Implantation iStent inject: Trabecular meshwork implantation
Change in the Number of Ocular Hypotensive Medications Compared to Screening	1 number of hypotensive medications	—	—

SECONDARY outcome

Timeframe: 1 week

Population: The number analyzed is zero for 2 arms in the study that did not have any subjects treated.

Outcome measures

Outcome measures
Measure	Ab-interno Transluminal Viscoelastic Delivery With Trabeculotomy Using OMNI Surgical System n=1 Participants OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System	Ab-interno Transluminal Viscoelastic Delivery Using OMNI Surgical System OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System	iStent Inject Implantation iStent inject: Trabecular meshwork implantation
Change in Unmedicated Diurnal Intraocular Pressure (DIOP) From Baseline	13.3 mmHg	—	—

Adverse Events

Ab-interno Transluminal Viscoelastic Delivery With Trabeculotomy Using OMNI Surgical System

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Ab-interno Transluminal Viscoelastic Delivery Using OMNI Surgical System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

iStent Inject Implantation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ab-interno Transluminal Viscoelastic Delivery With Trabeculotomy Using OMNI Surgical System n=1 participants at risk OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System	Ab-interno Transluminal Viscoelastic Delivery Using OMNI Surgical System OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System	iStent Inject Implantation iStent inject: Trabecular meshwork implantation
Eye disorders Mild Blepharitis	100.0% 1/1 • Number of events 1 • 1 month There were no subjects enrolled in 2 arms that are showing zero "at risk" for AEs, SAEs or all cause mortality	— 0/0 • 1 month There were no subjects enrolled in 2 arms that are showing zero "at risk" for AEs, SAEs or all cause mortality	— 0/0 • 1 month There were no subjects enrolled in 2 arms that are showing zero "at risk" for AEs, SAEs or all cause mortality

Additional Information

Kavita Dhamdhere, MD, PhD

Sight Sciences, Inc.

Phone: 877-266-1144

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60