Primary Open Angle GlaucomaPhase 4EVOLVENCT06407973
A Clinical Trial Comparing the OMNI Surgical System to Standard Medical Treatment in Patients With Primary Open Angle Glaucoma
A Phase 4 study testing OMNI Surgical System and Latanoprost plus adjunctive glaucoma medication in people with Primary Open Angle Glaucoma, run by Sight Sciences, Inc. at 2 sites in United States.
Trial summary
A Randomized Clinical Trial of Ab Interno Canaloplasty and Trabeculotomy with the OMNI® Surgical System Compared to Standard Medical Treatment as a Standalone Procedure in Patients with Primary Open Angle Glaucoma (EVOLVE) Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma
- What is being tested?
- OMNI Surgical System and Latanoprost plus adjunctive glaucoma medication
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Aug 2024to 20 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 (pseudophakic subjects), OR, phakic and no anticipated need for cataract surgery over the study duration.
- Under treatment with a topical prostaglandin F2 analog (e.g. latanoprost, travoprost, bimatoprost, tafluprost) either as monotherapy or in combination with one (1) adjunctive medication for a minimum of 6 weeks prior to the Screening visit.
- Intraocular pressure (IOP) at the Screening visit of >18 and not exceeding 36 mmHg.
- Diagnosed with primary open angle glaucoma (POAG).
Who cannot join
- Any of the following prior ocular procedures:
- Laser trabeculoplasty ≤180 days prior to baseline
- Durysta ≤12 months prior to baseline unless failure is documented and topical medication including a prostaglandin analog is in use as per Inclusion criterion # 3.
- Implanted with iStent (All types), Cypass, Xen, Express, glaucoma draining device/valve, or Hydrus Device; or
- Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy, endoscopic cyclophotocoagulation (ECP), Cyclophotocoagulation or CPC (G probe)
- Retinal laser procedure ≤3 months prior to baseline
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- Concurrent IOP-lowering procedure other than the study procedure (OSS) (e.g. ECP, CPC,etc.)
- Forms of glaucoma other than POAG including but not limited to: Pigmentary, pseudoexfoliative, acute angle closure, normal tension, pre-perimetric, traumatic, congenital, malignant, uveitic, neovascular or severe glaucoma as documented in subject's medical record.
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University Eye Specialists
Maryville, Tennessee, 37803
North Bay Eye Associates
Petaluma, California, 94954
About this study
Official title: A Randomized Clinical Trial of ab Interno Canaloplasty and Trabeculotomy With the OMNI Surgical System Compared to Standard Medical Treatment as a Standalone Procedure in Patients With Primary Open Angle Glaucoma
A Randomized Clinical Trial of Ab Interno Canaloplasty and Trabeculotomy with the OMNI® Surgical System Compared to Standard Medical Treatment as a Standalone Procedure in Patients with Primary Open Angle Glaucoma (EVOLVE)
Read the detailed description
This prospective, multicenter, post-market clinical trial will evaluate the safety and effectiveness of canaloplasty and trabeculotomy using the OSS as a standalone procedure in patients with POAG.
- Conditions
- Primary Open Angle Glaucoma
- Being tested
- OMNI Surgical System, Latanoprost plus adjunctive glaucoma medication
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMNI Surgical SystemDevice
Also called OMNI
The OMNI Surgical System is 510(k) cleared and 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
Latanoprost plus adjunctive glaucoma medicationDrug
- Latanoprost ophthalmic solution (0.005%) is a topical prostaglandin F2 analog used in the treatment of Glaucoma.
- Adjunctive topical glaucoma medication(s) as selected by the Investigator
| Study group | Role | What they receive |
|---|---|---|
| Surgical (OMNI Surgical System (OSS)) | Active comparator | Canaloplasty followed by Trabeculotomy using the OMNI Surgical System. Receives: Device: OMNI Surgical System |
| Standard Medical Care (SMC) | Active comparator | Standard Medical Care with Latanoprost and one or two adjunctive glaucoma medications at the discretion of the Principal Investigator Receives: Drug: Latanoprost plus adjunctive glaucoma medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects with a ≥ 20% reduction
Proportion of subjects with a ≥ 20% reduction from medicated baseline in mean diurnal IOP (DIOP) at 12 months post-operatively
Measured: 12 months
Secondary outcomes (5)
Diurnal IOP (DIOP) between 6 and 18 mmHg (inclusive)
Proportion of eyes at 12 months post-randomization, with mean medicated diurnal IOP (DIOP) between 6 and 18 mmHg (inclusive).
Measured: 12 months
Number of Ocular Hypotensive Medications
Mean number of ocular hypotensive medications used at 12 months
Measured: 12 months
Tear break-up time (TBUT)
Proportion of eyes with a minimal clinically important difference (MCID) defined as a 1 category improvement, in tear beak-up time (TBUT)
Measured: 12 months
Corneal or conjunctival staining
Proportion of eyes with improvement in corneal staining or conjunctival staining by at least one category with no worsening in either at 12 months compared to baseline.
Measured: 12 months
OSDI score
Proportion of subjects with a MCID in ocular surface disease index (OSDI) score at 12 months compared to baseline
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start21 Aug 2024
- Primary completion20 Jan 2025
- Study completion20 Jan 2025
Why it stopped: Business decision by the Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled open label
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sight Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407973
- Sponsor's protocol ID
- 09074
- Acronym
- EVOLVE
- Status last verified
- Jan 2025
- First submitted
- 6 May 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of ab Interno Canaloplasty and Trabeculotomy With the OMNI Surgical System Compared to Standard Medical Treatment as a Standalone Procedure in Patients With Primary Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT06407973
- Acronym / sponsor ID
- EVOLVE / 09074
- Conditions
- Primary Open Angle Glaucoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision by the Sponsor
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Sight Sciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Randomized Clinical Trial of Ab Interno Canaloplasty and Trabeculotomy with the OMNI® Surgical System Compared to Standard Medical Treatment as a Standalone Procedure in Patients with Primary Open Angle Glaucoma (EVOLVE)
Detailed description
This prospective, multicenter, post-market clinical trial will evaluate the safety and effectiveness of canaloplasty and trabeculotomy using the OSS as a standalone procedure in patients with POAG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled open label
| Arm | Type | Receives |
|---|---|---|
| Surgical (OMNI Surgical System (OSS)) | Active comparator | Device: OMNI Surgical SystemCanaloplasty followed by Trabeculotomy using the OMNI Surgical System. |
| Standard Medical Care (SMC) | Active comparator | Drug: Latanoprost plus adjunctive glaucoma medicationStandard Medical Care with Latanoprost and one or two adjunctive glaucoma medications at the discretion of the Principal Investigator |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (pseudophakic subjects), OR, phakic and no anticipated need for cataract surgery over the study duration.
- Under treatment with a topical prostaglandin F2 analog (e.g. latanoprost, travoprost, bimatoprost, tafluprost) either as monotherapy or in combination with one (1) adjunctive medication for a minimum of 6 weeks prior to the Screening visit.
- Intraocular pressure (IOP) at the Screening visit of >18 and not exceeding 36 mmHg.
- Diagnosed with primary open angle glaucoma (POAG).
Key exclusion criteria (9 listed)
- Any of the following prior ocular procedures:
- Concurrent IOP-lowering procedure other than the study procedure (OSS) (e.g. ECP, CPC,etc.)
- Forms of glaucoma other than POAG including but not limited to: Pigmentary, pseudoexfoliative, acute angle closure, normal tension, pre-perimetric, traumatic, congenital, malignant, uveitic, neovascular or severe glaucoma as documented in subject's medical record.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OMNI Surgical SystemAlso: OMNIThe OMNI Surgical System is 510(k) cleared and 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 | Device | Surgical (OMNI Surgical System (OSS)) |
| Latanoprost plus adjunctive glaucoma medication* Latanoprost ophthalmic solution (0.005%) is a topical prostaglandin F2 analog used in the treatment of Glaucoma. * Adjunctive topical glaucoma medication(s) as selected by the Investigator | Drug | Standard Medical Care (SMC) |
Primary outcome
Subjects with a ≥ 20% reduction
Time frame: 12 months
Proportion of subjects with a ≥ 20% reduction from medicated baseline in mean diurnal IOP (DIOP) at 12 months post-operatively
5 secondary outcomes
Diurnal IOP (DIOP) between 6 and 18 mmHg (inclusive)
Time frame: 12 months
Number of Ocular Hypotensive Medications
Time frame: 12 months
Tear break-up time (TBUT)
Time frame: 12 months
Corneal or conjunctival staining
Time frame: 12 months
OSDI score
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Business decision by the Sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OMNI Surgical System and Latanoprost plus adjunctive glaucoma medication in people with Primary Open Angle Glaucoma, run by Sight Sciences, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business decision by the Sponsor). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjects with a ≥ 20% reduction (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.