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

Last updated: February 19, 2025
Sponsor: Colorado Ophthalmology Associates PC
Overall Status: Active - Recruiting

Phase

N/A

Condition

Glaucoma

Treatment

Systane Ultra

Rocklatan

Clinical Study ID

NCT06819046
KO-25-01
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients 18 years and older

  • Documented diagnosis of mild to moderate primary open angle glaucoma or ocularhypertension. Diagnosis of primary open angle glaucoma must be supported by thefollowing:

  • 24-2 SITA faster within the last 6 months

  • With a mean deviation of 0 to -12 dB, excluding patients that meet severecriteria 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, progressivenarrowing of the neuroretinal rim, diffuse or localized thinning of theparapapillary RNFL, optic disc asymmetry of the two eyes consistent withloss of neural tissue, or thinning of the RNFL/GCA on examination orimaging

  • Progressive thinning on SD-OCT of 7 microns in inferior and superiorquadrants or >4 micron loss in global RNFL thickness

  • Deviation from this ISNT rule (inferior, superior, nasal and temporalorder of RNFL thickness with the inferior RNFL quadrant being thethickness)

  • Candidate for bilateral SLT

  • Post-washout, post-SLT IOPs between 28-10

  • Gonioscopy findings of Schafer grade III and IV

Exclusion

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 studyprotocol

  • Current participation of study drugs or devices or within 6 months prior toscreening

  • Pregnant or planning to be pregnant throughout the study

  • Any condition in the opinion in the investigator that would potentially confound theresults of this study

Study Design

Total Participants: 70
Treatment Group(s): 2
Primary Treatment: Systane Ultra
Phase:
Study Start date:
February 14, 2025
Estimated Completion Date:
January 31, 2026

Connect with a study center

  • Colorado Ophthalmology Associates PC

    Denver, Colorado 50210
    United States

    Active - Recruiting

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