Improved Efficacy of Selective Laser Trabeculoplasty With the Addition of Rocklatan Post-treatment vs Artificial Tears Post-treatment

NCT ID: NCT06819046

Last Updated: 2025-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-14

Study Completion Date

2026-01-31

Brief Summary

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A randomized, single-site, parallel-group, prospective study of patients who are candidates for SLT, to study the effect of IOP change with Rocklatan vs artificial tears.

Detailed Description

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Conditions

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Glaucoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Rocklatan

netarsudil and latanoprost ophthalmic solution 0.02%/0.005%

Rocklatan

Intervention Type DRUG

netarsudil and latanoprost ophthalmic solution 0.02%/0.005%

Systane Ultra

artificial tears

Systane Ultra

Intervention Type DRUG

artificial tears

Interventions

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Rocklatan

netarsudil and latanoprost ophthalmic solution 0.02%/0.005%

Intervention Type DRUG

Systane Ultra

artificial tears

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients 18 years and older
* Documented diagnosis of mild to moderate primary open angle glaucoma or ocular hypertension. Diagnosis of primary open angle glaucoma must be supported by the following:

* 24-2 SITA faster within the last 6 months

\- With a mean deviation of 0 to -12 dB, excluding patients that meet severe criteria by having defects involving fixation or in two hemispheres.
* OCT RNFL and optic nerve examination within the last 6 months

* Diffuse or focal narrowing or notching of the optic disc rim, progressive narrowing of the neuroretinal rim, diffuse or localized thinning of the parapapillary RNFL, optic disc asymmetry of the two eyes consistent with loss of neural tissue, or thinning of the RNFL/GCA on examination or imaging
* Progressive thinning on SD-OCT of 7 microns in inferior and superior quadrants or \>4 micron loss in global RNFL thickness
* Deviation from this ISNT rule (inferior, superior, nasal and temporal order of RNFL thickness with the inferior RNFL quadrant being the thickness)
* Candidate for bilateral SLT
* Post-washout, post-SLT IOPs between 28-10
* Gonioscopy findings of Schafer grade III and IV

Exclusion Criteria

* Patients MD \<-12, HVF defects in both hemispheres or involving fixation
* Medication conditions that prevent SLT
* Prior use of rho kinase inhibitor
* Previous SLT performed on either eye
* Prior MIGS implanted in either eye
* Prior or current intolerance of a Rho kinase inhibitor
* Uncontrolled IOP on maximum tolerated medical therapy; unable to washout
* Narrow angles or other angle abnormalities
* History of corneal disease or dystrophy, including endothelial dysfunction
* History of corneal edema
* Current or history of intra-ocular infection or inflammation
* History of retinal diseases that will could affect diagnostic testing
* Anticipated use of intra-ocular or topical steroids not associated with the study protocol
* Current participation of study drugs or devices or within 6 months prior to screening
* Pregnant or planning to be pregnant throughout the study
* Any condition in the opinion in the investigator that would potentially confound the results of this study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sengi

INDUSTRY

Sponsor Role collaborator

Colorado Ophthalmology Associates PC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kingsley Okafor, MD

Role: PRINCIPAL_INVESTIGATOR

Colorado Ophthalmology Associates PC

Locations

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Colorado Ophthalmology Associates PC

Denver, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Cristian Mendez

Role: CONTACT

303-320-1777

Facility Contacts

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Cristian Mendez

Role: primary

303-320-1777

Other Identifiers

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KO-25-01

Identifier Type: -

Identifier Source: org_study_id

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