Use of the OMNI® Surgical System in Combination With Cataract Extraction in Open Angle Glaucoma

• Sponsor: Sight Sciences, Inc.
• Information provided by (Responsible Party): Sight Sciences, Inc.

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Open Angle Glaucoma	Device: Transluminal viscoelastic delivery and trabeculotomy	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	220 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Prospective, Multi‐Center, Post‐Market Study of Use of the OMNI® Surgical System in Combination With Cataract Extraction in Open Angle Glaucoma
Actual Study Start Date :	February 22, 2019
Estimated Primary Completion Date :	August 30, 2020
Estimated Study Completion Date :	December 31, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Viscoeleastic delivery & trabeculotomy; Patients with open angle glaucoma and cataract	Device: Transluminal viscoelastic delivery and trabeculotomy; Ab‐interno transluminal viscoelastic delivery and trabeculotomy using OMNI Surgical System

Outcome Measures

Primary Outcome Measures :

1. Change in mean unmedicated diurnal IOP [ Time Frame: 12 months ]
   Reduction in mean unmedicated diurnal IOP from baseline to 12 months
2. Change in mean number of IOP‐lowering medications [ Time Frame: 12 months ]
   Reduction in mean number of IOP‐lowering medications from screening to 12 months

Secondary Outcome Measures :

1. Percent of eyes with a ≥20% reduction in unmedicated diurnal IOP at 12 months [ Time Frame: 12 months ]
2. Percent of eyes with unmedicated diurnal IOP between 6 and 18 mmHg inclusive at 12 months [ Time Frame: 12 months ]

Other Outcome Measures:

1. Safety Endpoint- Adverse events [ Time Frame: 12 months ]
   Rates of ocular adverse events (intraoperative, postoperative)
2. Safety Endpoint- best corrected visual acuity [ Time Frame: 12 months ]
   Reduction in best corrected visual acuity (BCVA) from baseline (note: reduction in BCVA due to PCO will not be treated as a safety event)

Eligibility Criteria

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Ages Eligible for Study:	22 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

- (only one eye of each subject is eligible, and all ocular criteria apply 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) per AAO/AGS/ICD‐10 Glaucoma Stage Definitions.1
4. At screening, on 1‐3 IOP‐lowering medications2 with a medicated IOP ≤25 mmHg OR on zero (0) IOP‐lowering medications with an IOP 21‐30 mmHg.
5. At baseline, unmedicated diurnal IOP 21‐30 mmHg and, for subjects who were medicated at screening, IOP at least 3 mmHg higher than screening IOP.
6. Scheduled for cataract extraction followed by abinterno transluminal viscoelastic delivery and trabeculotomy using the OMNI Surgical System.
7. Shaffer grade of ≥ III 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. Understands and signs the informed consent.

Exclusion Criteria:

- (All criteria apply to the study eye; both eyes of a single subject need not be eligible):

1. Any of the following prior treatments for glaucoma:

   • Laser trabeculoplasty ≤3 months prior to baseline
   • iStent implanted ≤6 months prior to baseline
   • Implanted with 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 by AAO/AGS/ICD‐10 guideline
5. Use of oral hypotensive medication treatment for glaucoma
6. History of elevated IOP due to steroid response
7. In the investigator's judgement, predisposed to significant risk because of washout of ocular hypotensive medications.
8. 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).
9. 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.

Contacts and Locations

Contacts

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Contact: Kavita p Dhamdhere, MD, PhD	16502234062	kdhamdhere@sightsciences.com
Contact: Anne Ripley	6616458546	Anne@sightsciences.com

Locations

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United States, Texas
El Paso Eye Surgeons	Recruiting
El Paso, Texas, United States, 79902
Contact: Mark Gallardo, MD 915-542-0279 gallardomark@hotmail.com

Sponsors and Collaborators

Sight Sciences, Inc.

Investigators

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Study Director:	kavita p dhamdhere, MD, PhD	Sight Sciences

More Information

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Responsible Party:	Sight Sciences, Inc.
ClinicalTrials.gov Identifier:	NCT03861169 History of Changes
Other Study ID Numbers:	06213
First Posted:	March 4, 2019
Last Update Posted:	March 4, 2019
Last Verified:	February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		Yes
Device Product Not Approved or Cleared by U.S. FDA:		No
Product Manufactured in and Exported from the U.S.:		No

Additional relevant MeSH terms:

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Glaucoma; Cataract; Glaucoma, Open-Angle	Ocular Hypertension; Eye Diseases; Lens Diseases