Glaucoma
Conditions
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.
Interventions
DRUGRocklatan
netarsudil and latanoprost ophthalmic solution 0.02%/0.005%
DRUGSystane Ultra
artificial tears
Sponsors
Colorado Ophthalmology Associates PC
Sengi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean diurnal IOP | 6 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Change in mean diurnal IOP from baseline | 28 days of treatment |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKingsley Okafor, MD
Colorado Ophthalmology Associates PC
Outcome results
None listed