Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05044793
Other study ID # 07408
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 30, 2021
Est. completion date August 21, 2023

Study information

Verified date January 2024
Source Sight Sciences, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date August 21, 2023
Est. primary completion date August 21, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States El Paso Eye Surgeons El Paso Texas
United States Northern Ophthalmics Jenkintown Pennsylvania
United States Oklahoma Eye Surgeons Oklahoma City Oklahoma
United States Grene Vision Group Wichita Kansas

Sponsors (1)

Lead Sponsor Collaborator
Sight Sciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in intraocular pressure (IOP) Change in unmedicated mean diurnal IOP (DIOP) 24months
Primary Change in number of medications Change in the number of ocular hypotensive medications 24months
See also
  Status Clinical Trial Phase
Recruiting NCT06201455 - Evaluation of Phacogoniotomy in Medically-controlled POAG N/A
Recruiting NCT03369886 - The Relationship Between Macular OCTA and GCIPL and Their Combinational Index Using AI N/A
Active, not recruiting NCT04624698 - iStent Inject New Enrollment Post-Approval Study N/A
Recruiting NCT02679482 - Following Patients After Selective and Pascal Laser Trabeculoplasty for Treatment of Chronic Open-Angle Glaucoma N/A
Completed NCT02338362 - Inhaled Corticosteroids: Effect on Intraocular Pressure in Patients With Controlled Glaucoma Phase 4
Active, not recruiting NCT01430923 - Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost N/A
Completed NCT01489670 - Observational Study of Lumigan® 0.01% Treatment for Patients With Primary Open Angle Glaucoma or Ocular Hypertension N/A
Completed NCT00693485 - Safety and Effects of Brimonidine Intravitreal Implant in Patients With Glaucomatous Optic Neuropathy Phase 2
Completed NCT00753168 - Phase 1-2 Evaluation of OT-730 Eye Drops in Reducing the Intraocular Pressure in Patients With Ocular Hypertension or Open-Angle Glaucoma Phase 1/Phase 2
Completed NCT00051194 - A 6-week Safety & Efficacy Study of Combination Intraocular Pressure-lowering Therapy in Patients With Open-angle Glaucoma or Ocular Hypertension Phase 2
Recruiting NCT04920227 - Comparation of CLASS Combined With Phacoemulsification and CLASS Alone in the Treatment of Primary Open Angle Glaucoma N/A
Active, not recruiting NCT03868124 - Clinical Study Comparing Two Models of a Travoprost Intraocular Implant Phase 3
Completed NCT03267862 - Scleral Response to Intraocular Pressure (IOP) N/A
Recruiting NCT06066645 - Travoprost Intraocular Implant + iStent Infinite vs. iStent Infinite Alone Phase 3
Recruiting NCT04912362 - The Effectiveness of YAG Iridotomy in Preventing Peripheral Anterior Synechia After CLASS in Primary Open Angle Glaucoma N/A
Completed NCT04949802 - Glaucoma Surgery Using the ViaLase Laser System N/A
Recruiting NCT04038034 - Valuation of the Antioxidant and Neuroprotective Effects of CoQ10-MINIACTIVES® (COQUN® OS) in Patients Affected by Primary Open Angle Glaucoma N/A
Completed NCT04632329 - Negative Pressure Applied by the Equinox MPD for Severe Open Angle Glaucoma N/A
Completed NCT01215786 - Safety and Pharmacodynamics Study of AGN-207281 Ophthalmic Solutions Compared With Timolol Ophthalmic Solution or Placebo in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma Phase 1
Completed NCT00801437 - Non Interventional Study With Primary Open Angle Glaucoma and/or Ocular Hypertension Patients Treated With Xalacom® After Failure of Previous Antiglaucoma Therapy.