GlaucomaNCT06819046
Improved Efficacy of Selective Laser Trabeculoplasty With the Addition of Rocklatan Post-treatment vs Artificial Tears Post-treatment
An observational study of Glaucoma, run by Colorado Ophthalmology Associates PC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Rocklatan and Systane Ultra
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2025to 17 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients who are a candidate for bilateral SLT.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado Ophthalmology Associates PC
Denver, Colorado, 50210
About this study
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.
- Conditions
- Glaucoma
- Being tested
- Rocklatan, Systane Ultra
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocklatanDrug
netarsudil and latanoprost ophthalmic solution 0.02%/0.005%
Systane UltraDrug
artificial tears
| Study group | Role | What they receive |
|---|---|---|
| Rocklatan | netarsudil and latanoprost ophthalmic solution 0.02%/0.005% Receives: Drug: Rocklatan | |
| Systane Ultra | artificial tears Receives: Drug: Systane Ultra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean diurnal IOP
Measured: 6 weeks of treatment
Secondary outcomes (1)
Change in mean diurnal IOP from baseline
Measured: 28 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start14 Feb 2025
- Primary completion17 Dec 2025
- Study completion17 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado Ophthalmology Associates PC
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- Kingsley Okafor, MD, Principal investigator, Colorado Ophthalmology Associates PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819046
- Sponsor's protocol ID
- KO-25-01
- Status last verified
- Mar 2026
- First submitted
- 6 Feb 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Efficacy of Selective Laser Trabeculoplasty With the Addition of Rocklatan Post-treatment vs Artificial Tears Post-treatment
- ClinicalTrials.gov ID
- NCT06819046
- Acronym / sponsor ID
- KO-25-01
- Conditions
- Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Colorado Ophthalmology Associates PCUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 17 Dec 2025 (actual)
- Study completion
- 17 Dec 2025 (actual)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rocklatan | – | Drug: Rocklatannetarsudil and latanoprost ophthalmic solution 0.02%/0.005% |
| Systane Ultra | – | Drug: Systane Ultraartificial tears |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients who are a candidate for bilateral SLT.
Key inclusion criteria (11 listed)
- 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:
- Candidate for bilateral SLT
- Post-washout, post-SLT IOPs between 28-10
- Gonioscopy findings of Schafer grade III and IV
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rocklatannetarsudil and latanoprost ophthalmic solution 0.02%/0.005% | Drug | Rocklatan |
| Systane Ultraartificial tears | Drug | Systane Ultra |
Primary outcome
Mean diurnal IOP
Time frame: 6 weeks of treatment
1 secondary outcome
Change in mean diurnal IOP from baseline
Time frame: 28 days of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kingsley Okafor, MD principal investigator
Colorado Ophthalmology Associates PC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by Colorado Ophthalmology Associates PC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean diurnal IOP (time frame: 6 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.