Rocklatan vs Latanoprost Post-DSLT

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.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma
• Intervention / Treatment: Drug: Rocklatan 0.02%-0.005% Ophthalmic Solution; Drug: Latanoprost 0.005% Ophthalmic Solution

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Beaumont, Texas, United States, 77707
      • Recruiting
      • Eye Centers of Southeast Texas
      • Contact: Carol McKee; Phone Number: 409-833-0444; Email: cmckee@eyecentersbmt.com
      • Principal Investigator: Kevin Talbot, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rocklatan; netarsudil and latanoprost 0.02%/0.005%	Drug: Rocklatan 0.02%-0.005% Ophthalmic Solution; netarsudil and latanoprost 0.02%/0.005%
Active Comparator: Lantanoprost; 0.005%	Drug: Latanoprost 0.005% Ophthalmic Solution; Latanoprost 0.005%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in mean diurnal intraocular pressure (IOP) from baseline	3 months post-treatment initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean intraocular pressure (IOP) from baseline at each time of day	8am, 12pm, 4pm	3 months post-treatment initiation
Mean percentage decrease in intraocular pressure (IOP) from baseline	Measured using the Snellen chart at each follow-up visit.	3 months post-treatment initiation

Collaborators and Investigators

• Sponsor: Eye Centers of Southeast Texas
• Collaborators: Sengi
• Investigators: Principal Investigator: Kevin Talbot, MD, Eye Centers of Southeast Texas

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2026
• Primary Completion (Estimated): May 6, 2027
• Study Completion (Estimated): May 6, 2027

Study Registration Dates

• First Submitted: March 6, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Pharmaceutical Solutions; Pharmaceutical Preparations; Fatty Acids; Lipids; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Biological Factors; Solutions; Specialty Uses of Chemicals; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Autacoids; Inflammation Mediators; Latanoprost; Ophthalmic Solutions
• Other Study ID Numbers: KT-26-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes