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

• Sponsor: Sight Sciences, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05044793
• Collaborator: (none)
• Enrollment: 130
• Locations: 4
• Anticipated Duration (Months): 20
• Patients Per Site: 32.5
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the long-term safety and effectiveness of the OMNI® Surgical System in subjects who were treated under protocol #06213

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

Study Design

• Study Type: Observational
• Anticipated Enrollment: 130 participants
• Observational Model: Other
• Time Perspective: Other
• Official Title: A Multicenter Clinical Study To Assess The Long-Term Safety And Effectiveness Of The OMNI® Surgical System In Combination With Cataract Surgery In Eyes With Open Angle Glaucoma (GEMINI 2.0)
• Actual Study Start Date: Sep 30, 2021
• Anticipated Primary Completion Date: May 31, 2023
• Anticipated Study Completion Date: May 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Number of Subjects Enrolled	Device: OMNI® Surgical System; The OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.

Outcome Measures

Primary Outcome Measures

1. Change in intraocular pressure (IOP) [24months]

   Change in unmedicated mean diurnal IOP (DIOP)

2. Change in number of medications [24months]

   Change in the number of ocular hypotensive medications

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participated in, received treatment, and completed Protocol #06213

Exclusion Criteria:

• Systemic disease that, in the opinion of the Investigator, would put the subject's health at risk and/or prevent completion of required study visits

• Ocular pathology which, in the Investigator's judgment, would either place the subject at increased risk of complications, contraindicate washout, place the subject at risk of significant vision loss during the study period (e.g., wet age macular degeneration (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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Grene Vision Group	Wichita	Kansas	United States	62708
2	Oklahoma Eye Surgeons	Oklahoma City	Oklahoma	United States	73112
3	Northern Ophthalmics	Jenkintown	Pennsylvania	United States	19406
4	El Paso Eye Surgeons	El Paso	Texas	United States	79902

Sponsors and Collaborators

• Sight Sciences, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sight Sciences, Inc.
• ClinicalTrials.gov Identifier: NCT05044793
• Other Study ID Numbers: 07408
• First Posted: Sep 16, 2021
• Last Update Posted: Apr 15, 2022
• Last Verified: Apr 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
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle

Study Results

No Results Posted as of Apr 15, 2022