Clinical trial NCT06819046: Improved Efficacy of Selective Laser Trabeculoplasty With the Addition of Rocklatan Post-treatment vs Artificial Tears Post-treatment
Official title: Improved Efficacy of Selective Laser Trabeculoplasty With the Addition of Rocklatan Post-treatment vs Artificial Tears Post-treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glaucoma
Lead sponsor: Colorado Ophthalmology Associates PC
Sponsor class: OTHER
Collaborators: name: Sengi
First posted: 2025-02-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients who are a candidate for bilateral SLT.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean diurnal IOP
timeFrame: 6 weeks of treatment
Secondary outcomes:
measure: Change in mean diurnal IOP from baseline
timeFrame: 28 days of treatment
Other outcomes:
measure: Percentage of patients who reach >20% IOP reduction from baseline
timeFrame: 6 weeks of treatment
measure: Number of IOP spikes
timeFrame: 6 weeks of treatment
Locations:
city: Denver
country: United States
facility: Colorado Ophthalmology Associates PC
state: Colorado
Study officials:
affiliation: Colorado Ophthalmology Associates PC
name: Kingsley Okafor, MD
role: PRINCIPAL_INVESTIGATOR
References: