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Procedure

OMNI Surgical System for Glaucoma (EVOLVE Trial)

Phase 4
Recruiting
Research Sponsored by Sight Sciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female subjects, 45 years or older
History of uncomplicated cataract surgery and posterior chamber intraocular lens (IOL) implantation without compromise to the lens capsule, zonular dehiscence/rupture or vitreous prolapse, 6 months or more prior to Baseline Visit
Must not have
Concurrent IOP-lowering procedure other than the study procedure (OSS) (e.g. ECP, CPC,etc.)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial is comparing two surgical procedures, ab interno canaloplasty and trabeculotomy using the OMNI Surgical System, to standard medical treatment in patients with glaucoma who have already had

Who is the study for?
This trial is for people who have had cataract surgery (pseudophakic patients) and are now dealing with primary open-angle glaucoma, a common type of eye pressure problem. Participants should need additional treatment despite already using eye drops for glaucoma.
What is being tested?
The study is testing the OMNI Surgical System, which is a new procedure to help lower eye pressure, against standard treatments like Latanoprost and other glaucoma medications. Patients will be randomly assigned to one of these two approaches.
What are the potential side effects?
Potential side effects from the OMNI Surgical System may include discomfort in the eye, bleeding, infection or vision changes. Standard medications can cause redness, itching or stinging in the eyes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 45 years old or older.
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I had successful cataract surgery with lens implant over 6 months ago without complications.
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I have been diagnosed with primary open angle glaucoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not undergoing any eye pressure-lowering treatments other than the study's.
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I am not pregnant, breastfeeding, and agree to use birth control during the study.
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I have a type of glaucoma that is not primary open-angle.
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I have had a specific eye surgery or device implant for glaucoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Subjects with a ≥ 20% reduction
Secondary study objectives
Corneal or conjunctival staining
Diurnal IOP (DIOP) between 6 and 18 mmHg (inclusive)
Number of Ocular Hypotensive Medications
+2 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Standard Medical Care (SMC)Active Control1 Intervention
Standard Medical Care with Latanoprost and an adjunctive glaucoma medication at the discretion of the Principal Investigator
Group II: Surgical (OMNI Surgical System (OSS))Active Control1 Intervention
Canaloplasty followed by Trabeculotomy using the OMNI Surgical System.

Find a Location

Who is running the clinical trial?

Sight Sciences, Inc.Lead Sponsor
13 Previous Clinical Trials
1,004 Total Patients Enrolled
7 Trials studying Glaucoma
437 Patients Enrolled for Glaucoma
~223 spots leftby May 2027
Unbiased ResultsWe believe in providing patients with all the options.
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