GlaucomaPhase 4NCT07465913
Rocklatan vs Latanoprost Post-DSLT
A Phase 4 study testing Rocklatan 0.02%-0.005% Ophthalmic Solution and Latanoprost 0.005% Ophthalmic Solution in people with Glaucoma, run by Eye Centers of Southeast Texas at 1 site in United States.
Trial summary
This is a randomized, double-masked, single-site, prospective, contralateral eye study designed to evaluate the outcomes of Direct Selective Laser Trabeculoplasty (DSLT) followed by the addition of combination netarsudil and latanoprost (Rocklatan) versus latanoprost monotherapy. 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 0.02%-0.005% Ophthalmic Solution and Latanoprost 0.005% Ophthalmic Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2026to 6 May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years) with a diagnosis of mild to moderate bilateral primary open-angle glaucoma (POAG) or open-angle glaucoma (OAG).
- On 3 topical glaucoma medications at screening, one of which must be a prostaglandin analog.
- Post-DSLT and post-washout, baseline intraocular pressure (IOP) 16-36 mmHg in both eyes.
- Best-corrected visual acuity (BCVA) ≥20/60 in both eyes.
- Ability and willingness to provide informed consent.
Who cannot join
- Ocular hypertension only (no glaucomatous damage).
- Inability or medical ineligibility for washout of ocular hypotensive medications.
- Prior selective laser trabeculoplasty (SLT) within 12 months of screening.
- History of glaucoma surgery (trabeculectomy, tube shunt, minimally invasive glaucoma surgery [MIGS] affecting outflow).
- Narrow or closed angles with gonioscopy (Shaffer grading ≤2).
- Active ocular infection, uveitis, or severe dry eye.
Show all 10Show fewer
- Corneal pathology interfering with IOP measurement.
- Advanced glaucoma (threat to fixation).
- Known hypersensitivity to Rocklatan, latanoprost, or study medication components.
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Eye Centers of Southeast Texas
Beaumont, Texas, 77707
Carol McKee, 409-833-0444, cmckee@eyecentersbmt.com
Kevin Talbot, MD
About this study
Official title: Outcomes of Direct Selective Laser Trabeculoplasty With the Post-treatment Addition of Combination Netarsudil and Latanoprost vs Latanoprost Monotherapy
This is a randomized, double-masked, single-site, prospective, contralateral eye study designed to evaluate the outcomes of Direct Selective Laser Trabeculoplasty (DSLT) followed by the addition of combination netarsudil and latanoprost (Rocklatan) versus latanoprost monotherapy. The study will be conducted at one investigational site. The primary endpoint is the change in mean diurnal intraocular pressure (IOP) from baseline (post DSLT and post washout) at visit 3 between the two groups. Secondary endpoints include the change in mean IOP from baseline at each timepoint (8am, 12pm, 4pm) at visit 3 between groups, and the mean percentage decrease in IOP from baseline for each group. Assessments will be conducted at three key visits: Visit 1 (Screening Phase and DSLT Procedure on Day 0), Visit 2 (Baseline Visit post washout at Week 8), and Visit 3 (Follow-Up Visit 1 at Week 12). Each visit will include specific examinations and measurements such as visual field and OCT imaging, diurnal IOP measurements, and documentation of adverse events.
- Conditions
- Glaucoma
- Being tested
- Rocklatan 0.02%-0.005% Ophthalmic Solution, Latanoprost 0.005% Ophthalmic Solution
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocklatan 0.02%-0.005% Ophthalmic SolutionDrug
netarsudil and latanoprost 0.02%/0.005%
Latanoprost 0.005% Ophthalmic SolutionDrug
Latanoprost 0.005%
| Study group | Role | What they receive |
|---|---|---|
| Rocklatan | Experimental | netarsudil and latanoprost 0.02%/0.005% Receives: Drug: Rocklatan 0.02%-0.005% Ophthalmic Solution |
| Lantanoprost | Active comparator | 0.005% Receives: Drug: Latanoprost 0.005% Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean diurnal intraocular pressure (IOP) from baseline
Measured: 3 months post-treatment initiation
Secondary outcomes (2)
Change in mean intraocular pressure (IOP) from baseline at each time of day
8am, 12pm, 4pm
Measured: 3 months post-treatment initiation
Mean percentage decrease in intraocular pressure (IOP) from baseline
Measured using the Snellen chart at each follow-up visit.
Measured: 3 months post-treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start14 May 2026
- Primary completion6 May 2027 (estimated)
- Study completion6 May 2027 (estimated)
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Contralateral eye study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye Centers of Southeast Texas
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- Kevin Talbot, MD, Principal investigator, Eye Centers of Southeast Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465913
- Sponsor's protocol ID
- KT-26-01
- Status last verified
- May 2026
- First submitted
- 6 Mar 2026
- Last updated
- 22 May 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Direct Selective Laser Trabeculoplasty With the Post-treatment Addition of Combination Netarsudil and Latanoprost vs Latanoprost Monotherapy
- ClinicalTrials.gov ID
- NCT07465913
- Acronym / sponsor ID
- KT-26-01
- Conditions
- Glaucoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Eye Centers of Southeast TexasUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 14 May 2026 (actual)
- Primary completion
- 6 May 2027 (estimated)
- Study completion
- 6 May 2027 (estimated)
- First posted
- 12 Mar 2026 (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.
This is a randomized, double-masked, single-site, prospective, contralateral eye study designed to evaluate the outcomes of Direct Selective Laser Trabeculoplasty (DSLT) followed by the addition of combination netarsudil and latanoprost (Rocklatan) versus latanoprost monotherapy. The study will be conducted at one investigational site. The primary endpoint is the change in mean diurnal intraocular pressure (IOP) from baseline (post DSLT and post washout) at visit 3 between the two groups. Secondary endpoints include the change in mean IOP from baseline at each timepoint (8am, 12pm, 4pm) at visit 3 between groups, and the mean percentage decrease in IOP from baseline for each group. Assessments will be conducted at three key visits: Visit 1 (Screening Phase and DSLT Procedure on Day 0), Visit 2 (Baseline Visit post washout at Week 8), and Visit 3 (Follow-Up Visit 1 at Week 12). Each visit will include specific examinations and measurements such as visual field and OCT imaging, diurnal IOP measurements, and documentation of adverse events.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Contralateral eye study
| Arm | Type | Receives |
|---|---|---|
| Rocklatan | Experimental | Drug: Rocklatan 0.02%-0.005% Ophthalmic Solutionnetarsudil and latanoprost 0.02%/0.005% |
| Lantanoprost | Active comparator | Drug: Latanoprost 0.005% Ophthalmic Solution0.005% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults (≥18 years) with a diagnosis of mild to moderate bilateral primary open-angle glaucoma (POAG) or open-angle glaucoma (OAG).
- On 3 topical glaucoma medications at screening, one of which must be a prostaglandin analog.
- Post-DSLT and post-washout, baseline intraocular pressure (IOP) 16-36 mmHg in both eyes.
- Best-corrected visual acuity (BCVA) ≥20/60 in both eyes.
- Ability and willingness to provide informed consent.
Key exclusion criteria (10 listed)
- Ocular hypertension only (no glaucomatous damage).
- Inability or medical ineligibility for washout of ocular hypotensive medications.
- Prior selective laser trabeculoplasty (SLT) within 12 months of screening.
- History of glaucoma surgery (trabeculectomy, tube shunt, minimally invasive glaucoma surgery [MIGS] affecting outflow).
- Narrow or closed angles with gonioscopy (Shaffer grading ≤2).
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 |
|---|---|---|
| Rocklatan 0.02%-0.005% Ophthalmic Solutionnetarsudil and latanoprost 0.02%/0.005% | Drug | Rocklatan |
| Latanoprost 0.005% Ophthalmic SolutionLatanoprost 0.005% | Drug | Lantanoprost |
Primary outcome
Change in mean diurnal intraocular pressure (IOP) from baseline
Time frame: 3 months post-treatment initiation
2 secondary outcomes
Change in mean intraocular pressure (IOP) from baseline at each time of day
Time frame: 3 months post-treatment initiation
Mean percentage decrease in intraocular pressure (IOP) from baseline
Time frame: 3 months post-treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
Related trials for Glaucoma
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
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.
Kevin Talbot, MD principal investigator
Eye Centers of Southeast Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rocklatan 0.02%-0.005% Ophthalmic Solution and Latanoprost 0.005% Ophthalmic Solution in people with Glaucoma, run by Eye Centers of Southeast Texas 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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 22 May 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean diurnal intraocular pressure (IOP) from baseline (time frame: 3 months post-treatment initiation). 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 22 May 2026.