NCT07465913 Rocklatan vs Latanoprost Post-DSLT
| NCT ID | NCT07465913 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Eye Centers of Southeast Texas |
| Condition | Glaucoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2026-05-14 |
| Primary Completion | 2027-05-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 36 participants in total. It began in 2026-05-14 with a primary completion date of 2027-05-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Corneal pathology interfering with IOP measurement. * Advanced glaucoma (threat to fixation). * Known hypersensitivity to Rocklatan, latanoprost, or study medication components. * Pregnancy or lactation.
Contact & Investigator
Kevin Talbot, MD
PRINCIPAL INVESTIGATOR
Eye Centers of Southeast Texas
Frequently Asked Questions
Who can join the NCT07465913 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glaucoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07465913 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07465913 currently recruiting?
Yes, NCT07465913 is actively recruiting participants. Visit ClinicalTrials.gov or contact Eye Centers of Southeast Texas to inquire about joining.
Where is the NCT07465913 trial being conducted?
This trial is being conducted at Beaumont, United States.
Who is sponsoring the NCT07465913 clinical trial?
NCT07465913 is sponsored by Eye Centers of Southeast Texas. The principal investigator is Kevin Talbot, MD at Eye Centers of Southeast Texas. The trial plans to enroll 36 participants.