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

NCT06819046 | Completed FDA Drug

• 1 other identifier: KO-25-01
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• Mean diurnal IOP

  6 weeks of treatment

Secondary Outcomes (1)

• Change in mean diurnal IOP from baseline

  28 days of treatment

Other Outcomes (2)

• Percentage of patients who reach >20% IOP reduction from baseline

  6 weeks of treatment

• Number of IOP spikes

  6 weeks of treatment

Study Arms (2)

Rocklatan

netarsudil and latanoprost ophthalmic solution 0.02%/0.005%

Drug: Rocklatan

Systane Ultra

artificial tears

Drug: Systane Ultra

Interventions

Systane Ultra DRUG

artificial tears

Systane Ultra

Rocklatan DRUG

netarsudil and latanoprost ophthalmic solution 0.02%/0.005%

Rocklatan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients who are a candidate for bilateral SLT.

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Colorado Ophthalmology Associates PC: lead
• Sengi: collaborator

Study Sites (1)

Colorado Ophthalmology Associates PC

Denver, Colorado, 50210, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Kingsley Okafor, MD

  Colorado Ophthalmology Associates PC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 11, 2025
• Study Start: February 14, 2025
• Primary Completion: December 17, 2025
• Study Completion: December 17, 2025
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)