ORION: A Prospective, Multicenter Study of the OMNI® Surgical System in Pseudophakic Eyes With Open Angle Glaucoma

• Sponsor: Sight Sciences, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT04465630
• Collaborator: (none)
• Enrollment: 78
• Locations: 11
• Arm: 1
• Actual Duration (Months): 8.4
• Patients Per Site: 7.1
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

To prospectively assess the clinical effect of ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System in pseudophakic eyes on intraocular pressure (IOP) and the use of IOP-lowering medications in patients with open angle glaucoma (OAG).

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Open-Angle	Device: OMNI® Surgical System	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 78 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Multicenter Study of the OMNI® Surgical System in Pseudophakic Eyes With Open Angle Glaucoma
• Actual Study Start Date: Jun 19, 2020
• Actual Primary Completion Date: Mar 2, 2021
• Actual Study Completion Date: Mar 2, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Pseudophakic eyes with Open Angle Glaucoma Eligible subjects enrolled in the trial will receive surgery for Open Angle Glaucoma using the OMNI® Surgical System.	Device: OMNI® Surgical System; Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System

Outcome Measures

Primary Outcome Measures

1. Change in Intraocular Pressure (IOP) [6 months]

   Change in unmedicated mean diurnal IOP (DIOP) for subjects who reached the 6-month post-operative timepoint by the time of study closure

Secondary Outcome Measures

1. Change in Number of Medications [6 months]

   Change in the number of ocular hypotensive medications between screening and 6 months for subjects who reached the 6-month post-operative timepoint by the time of study closure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female subjects, 22 years or older at the time of surgery

• History of uncomplicated cataract surgery and posterior chamber IOL implantation without compromise to the lens capsule, zonular dehiscence/rupture or vitreous prolapse, 6 months or more prior to Baseline Visit.

• Diagnosed with mild to moderate open angle glaucoma (e.g. primary open angle glaucoma, pigmentary glaucoma, pseudoexfoliative glaucoma) as documented in subjects' medical record substantiated using funduscopic exam or OCT and at least one visual field test with the Humphrey automated perimeter using the SITA Standard 24-2 testing algorithm.

• Mean deviation score must be better than or equal to -12.0 dB

• The visual field test may be historical (within 6 months prior to Screening Visit). If needed, visual field testing may be repeated between the Screening Visit and the Surgery Visit.

• At the Screening visit, IOP of ≤ 36 mmHg while on 1-5 ocular hypotensive medications1 with a stable medication regimen for at least 2 months.

• At Baseline visit, unmedicated diurnal i) IOP ≥ 22.5 and ≤ 39mmHg and ii) IOP at least 3 mmHg higher than screening IOP and iii) IOP at 7:30AM ≥ 24

• Scheduled for ab-interno transluminal viscoelastic delivery and trabeculotomy using the OMNI Surgical System.

• Shaffer grade of ≥ III in all four quadrants

• Able and willing to comply with the protocol, including all follow-up visits.

• Understands and signs the informed consent

Exclusion Criteria:

• Any of the following prior treatments for glaucoma:

• Laser trabeculoplasty ≤3 months prior to Baseline visit

• iStent or iStent Inject implanted ≤6 months prior to Baseline visit

• Endocyclophotocoagulation (ECP) or Micropulse laser ≤ 6 months prior to Baseline visit

• Trabeculectomy or other bleb forming procedure including Xen, Express, glaucoma draining device/valve

• Prior canaloplasty, goniotomy, or trabeculotomy

• Hydrus microstent

• Suprachoroidal stent (e.g. Cypass, iStent Supra)

• Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma

• Concurrent IOP-lowering procedure other than use of the OMNI Surgical System at the time of surgery (e.g. ECP, CPC, etc.)

• In the Investigator's judgement, predisposed to significant risk because of washout of ocular hypotensive medications

• Concurrent ocular pathology or systemic 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, active intraocular infection or inflammation within 30 days prior to Screening Visit, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to Investigator's office for follow-up visits).

• History of penetrating keratoplasty or another corneal transplant

• BCVA of logMAR 1.0 (20/200) or worse in the fellow eye not due to cataract

• Study of OMNI System in POAG

• BCVA of logMAR 0.4 (20/50) or worse in the study eye not due to posterior capsular opacification (uneventful Nd:YAG laser capsulotomy 6 months prior to baseline is permitted only if there is no vitreous present in or in front of the iris plane at the time of baseline).

• 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

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vold Vision	Fayetteville	Arkansas	United States	72704
2	Visionary Eye Institute	Newport Beach	California	United States	92663
3	North Bay Eye Associates	Petaluma	California	United States	94954
4	Assil Eye Institute	Santa Monica	California	United States	90404
5	Grene Vision Group	Wichita	Kansas	United States	62708
6	Minnesota Eye Consultants	Bloomington	Minnesota	United States	55431
7	Oklahoma Eye Surgeons	Oklahoma City	Oklahoma	United States	73112
8	University Eye Specialists	Maryville	Tennessee	United States	37803
9	El Paso Eye Surgeons	El Paso	Texas	United States	79902
10	Ophthalmology Associates - Fort Worth	Fort Worth	Texas	United States	76102
11	Utah Eye Centers	Ogden	Utah	United States	84403

Sponsors and Collaborators

• Sight Sciences, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 4, 2020

More Information

Publications

None provided.

• Responsible Party: Sight Sciences, Inc.
• ClinicalTrials.gov Identifier: NCT04465630
• Other Study ID Numbers: 06807
• First Posted: Jul 10, 2020
• Last Update Posted: Jun 28, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle

Study Results

Participant Flow

Recruitment Details	The enrollment period for the study lasted 7 months and the study included 11 sites across the USA

Arm/Group Title	Pseudophakic Eyes With Open Angle Glaucoma
Arm/Group Description	One eye of each eligible subject enrolled in the trial will receive surgery for Open Angle Glaucoma using the OMNI® Surgical System. OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System
Period Title: Overall Study
STARTED	78
COMPLETED	0
NOT COMPLETED	78

Baseline Characteristics

Arm/Group Title	Pseudophakic Eyes With Open Angle Glaucoma
Arm/Group Description	Eligible subjects enrolled in the trial will receive surgery for Open Angle Glaucoma using the OMNI® Surgical System. OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System
Overall Participants	54
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	9 16.7%
>=65 years	45 83.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	73.2 (7.6)
Sex: Female, Male (Count of Participants)
Female	35 64.8%
Male	19 35.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 1.9%
Asian	1 1.9%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 1.9%
White	51 94.4%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	54 100%

Outcome Measures

1. Primary Outcome

Title	Change in Intraocular Pressure (IOP)
Description	Change in unmedicated mean diurnal IOP (DIOP) for subjects who reached the 6-month post-operative timepoint by the time of study closure
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Overall mean change in IOP from baseline for subjects who reached the 6-month time point by study closure

Arm/Group Title	Pseudophakic Eyes With Open Angle Glaucoma
Arm/Group Description	One eye of each eligible subjects enrolled in the trial will receive surgery for Open Angle Glaucoma using the OMNI® Surgical System. OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System
Measure Participants	14
Mean (Standard Deviation) [mmHg]	-8.8 (7.3)

2. Secondary Outcome

Title	Change in Number of Medications
Description	Change in the number of ocular hypotensive medications between screening and 6 months for subjects who reached the 6-month post-operative timepoint by the time of study closure
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Overall mean change in number of ocular hypotensive medications from Screening for enrolled subjects who reached the 6-month post-operative time point at the time of study closure

Arm/Group Title	Pseudophakic Eyes With Open Angle Glaucoma
Arm/Group Description	Eligible subjects enrolled in the trial will receive surgery for Open Angle Glaucoma using the OMNI® Surgical System. OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System
Measure Participants	14
Mean (Standard Deviation) [number of hypotensive medications]	-1.2 (1.3)

Adverse Events

Time Frame	6 months
Arm/Group Title	Pseudophakic Eyes With Open Angle Glaucoma
Arm/Group Description	Eligible subjects enrolled in the trial will receive surgery for Open Angle Glaucoma using the OMNI® Surgical System. OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System
All Cause Mortality
	Pseudophakic Eyes With Open Angle Glaucoma
	Affected / at Risk (%)	# Events
Total	0/78 (0%)
Serious Adverse Events
	Pseudophakic Eyes With Open Angle Glaucoma
	Affected / at Risk (%)	# Events
Total	2/78 (2.6%)
Cardiac disorders
Coronary Artery Disease (unrelated)	1/78 (1.3%)	1
Renal and urinary disorders
Renal Failure (unrelated)	1/78 (1.3%)	1
Other (Not Including Serious) Adverse Events
	Pseudophakic Eyes With Open Angle Glaucoma
	Affected / at Risk (%)	# Events
Total	20/78 (25.6%)
Eye disorders
Vitreous Hemorrhage (unrelated)	1/78 (1.3%)	1
Iris Prolapse (unrelated)	1/78 (1.3%)	1
Posterior Capsular Opacification (unrelated)	1/78 (1.3%)	1
Corneal edema after 1 week	1/78 (1.3%)	1
Layered hyphema greater than or equal to 1mm (unrelated)	3/78 (3.8%)	3
Clinically significant cystoid macular edema (unrelated)	1/78 (1.3%)	1
IOP increase of 10 mmHg above baseline IOP at 1 month or later	1/78 (1.3%)	1
Benign paroxysmal positional vertigo (unrelated)	1/78 (1.3%)	1
Blepharitis (unrelated)	1/78 (1.3%)	1
Eye pain	1/78 (1.3%)	1
Headache (unrelated)	1/78 (1.3%)	1
Headache above left eye (unrelated)	1/78 (1.3%)	1
Iris atrophy (unrelated)	1/78 (1.3%)	1
Iris prolapse (unrelated)	1/78 (1.3%)	1
Macular edema (unrelated)	1/78 (1.3%)	1
Small blood clots in trabecular meshwork (unrelated)	1/78 (1.3%)	1
Superficial punctate keratitis (unrelated)	1/78 (1.3%)	1
Respiratory, thoracic and mediastinal disorders
COVID-19 (unrelated)	1/78 (1.3%)	1

Limitations/Caveats

Meaningful conclusions cannot be drawn due to early termination of the study due to a business decision.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Depending on certain terms described in the agreement, the Institution and Principal Investigator may publish the results of the Study generated by the Institution, subject to...the prior approval of Sponsor in writing. The Institution shall furnish Sponsor with a written copy of any proposed publication or disclosure,...at least sixty (60) days prior to submission for publication or disclosure.