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

Colorado Ophthalmology Associates PC

Status

Enrolling

Conditions

Glaucoma

Treatments

Drug: Rocklatan

Drug: Systane Ultra

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT06819046

KO-25-01

Details and patient eligibility

About

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.

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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