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
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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RECRUITING
70 participants
OBSERVATIONAL
2025-02-14
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Rocklatan
netarsudil and latanoprost ophthalmic solution 0.02%/0.005%
Rocklatan
netarsudil and latanoprost ophthalmic solution 0.02%/0.005%
Systane Ultra
artificial tears
Systane Ultra
artificial tears
Interventions
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Rocklatan
netarsudil and latanoprost ophthalmic solution 0.02%/0.005%
Systane Ultra
artificial tears
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Sengi
INDUSTRY
Colorado Ophthalmology Associates PC
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KO-25-01
Identifier Type: -
Identifier Source: org_study_id
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