Comparing Rocklatan and artificial tears after laser treatment for glaucoma
Improved Efficacy of Selective Laser Trabeculoplasty With the Addition of Rocklatan Post-treatment vs Artificial Tears Post-treatment
Colorado Ophthalmology Associates PC · NCT06819046
This study tests whether Rocklatan works better than artificial tears in helping people with glaucoma manage their eye pressure after laser treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Colorado Ophthalmology Associates PC (other) |
| Locations | 1 site (Denver, Colorado) |
| Trial ID | NCT06819046 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of Rocklatan compared to artificial tears in managing intraocular pressure (IOP) changes in patients undergoing selective laser trabeculoplasty (SLT) for glaucoma. It involves a randomized, single-site, parallel-group design, focusing on patients diagnosed with mild to moderate primary open-angle glaucoma or ocular hypertension. Participants will receive either Rocklatan or artificial tears post-treatment, and their IOP changes will be monitored to assess the efficacy of the interventions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with mild to moderate primary open-angle glaucoma or ocular hypertension.
Not a fit: Patients with severe glaucoma or those who do not meet the specified diagnostic criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective post-treatment option for managing IOP in glaucoma patients.
How similar studies have performed: While there have been studies on the efficacy of various treatments for glaucoma, this specific comparison of Rocklatan and artificial tears post-SLT is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Denver, Colorado
- Colorado Ophthalmology Associates PC — Denver, Colorado, United States (RECRUITING)
Study contacts
- Principal investigator: Kingsley Okafor, MD — Colorado Ophthalmology Associates PC
- Study coordinator: Cristian Mendez
- Email: cmendez@coaeyes.com
- Phone: 303-320-1777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Glaucoma