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

NCT04616573 | Terminated Results FDA Device

• 1 other identifier: 07024
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

Brief Summary

To prospectively compare the clinical effect of the OMNI surgical system in eyes with Open Angle Glaucoma.

Conditions

Glaucoma, Open-Angle

Outcome Measures

Primary Outcomes (1)

• Change in Unmedicated Diurnal Intraocular Pressure (DIOP)

  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.

  1 week

Secondary Outcomes (4)

• Eyes With a ≥ 20% Decrease in Unmedicated Mean Diurnal Intraocular Pressure (DIOP) From Baseline

  1 week

• Eyes With Unmedicated Diurnal Intraocular Pressure (DIOP) Between 6 and 18 mmHg Inclusive

  1 week

• Change in the Number of Ocular Hypotensive Medications Compared to Screening

  1 week

• Change in Unmedicated Diurnal Intraocular Pressure (DIOP) From Baseline

  1 week

Study Arms (3)

Ab-interno transluminal viscoelastic delivery with trabeculotomy using OMNI surgical System

ACTIVE COMPARATOR

Ab-interno transluminal viscoelastic delivery with trabeculotomy using OMNI surgical System

Device: OMNI® Surgical System

Ab-interno transluminal viscoelastic delivery using OMNI surgical System

ACTIVE COMPARATOR

Ab-interno transluminal viscoelastic delivery using OMNI surgical System

Device: OMNI® Surgical System

iStent Inject implantation

ACTIVE COMPARATOR

iStent Inject implantation using the iStent device

Device: iStent inject

Interventions

OMNI® Surgical System DEVICE

Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System

Ab-interno transluminal viscoelastic delivery using OMNI surgical System; Ab-interno transluminal viscoelastic delivery with trabeculotomy using OMNI surgical System

iStent inject DEVICE

Trabecular meshwork implantation

iStent Inject implantation

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects, 22 years or older
• Visually significant cataract
• Mild to moderate open angle glaucoma
• On 1-5 IOP-lowering medications
• Potential of good best corrected visual acuity post cataract extraction, in the investigator's judgment
• Able and willing to comply with the protocol, including all follow-up visits.
• Understand and sign the informed consent.

You may not qualify if:

• Any of the following prior treatments for glaucoma:
• Laser trabeculoplasty ≤3 months prior to baseline
• Implanted with iStent (All types), Cypass, Xen, Express, glaucoma draining device/valve, or Hydrus Device
• Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy, ECP or CPC
• Acute angle closure, normal tension, traumatic, congenital, malignant, uveitic, neovascular or severe glaucoma as documented in subjects' medical record.
• 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).
• 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.

Sponsors & Collaborators

• Sight Sciences, Inc.: lead

Study Sites (2)

Eye Center South

Dothan, Alabama, 36301, United States

Location

Eye Associates and SurgiCenter of Vineland

Vineland, New Jersey, 08361, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Results Point of Contact

• Title: Kavita Dhamdhere, MD, PhD
• Organization: Sight Sciences, Inc.

kdhamdhere@sightsciences.com

877-266-1144

Study Officials

• Kavita Dhamdhere, MD, PhD

  Sight Sciences, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: November 5, 2020
• Study Start: November 13, 2020
• Primary Completion: January 20, 2021
• Study Completion: January 20, 2021
• Last Updated: December 1, 2022
• Results First Posted: December 1, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)