Phase
Condition
Glaucoma
Treatment
Systane Ultra
Rocklatan
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Connect with a study center
Colorado Ophthalmology Associates PC
Denver, Colorado 50210
United StatesActive - Recruiting
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