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Recruiting NCT07465913

Rocklatan vs Latanoprost Post-DSLT

Phase IV Interventional Glaucoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rocklatan 0.02%-0.005% Ophthalmic Solution, Latanoprost 0.005% Ophthalmic Solution.
Who it may be relevant to
Registry conditions: Glaucoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Outcomes of Direct Selective Laser Trabeculoplasty With the Post-treatment Addition of Combination Netarsudil and Latanoprost vs Latanoprost Monotherapy

Overview

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.

Interventions

  • Drug Rocklatan 0.02%-0.005% Ophthalmic Solution
    netarsudil and latanoprost 0.02%/0.005%
  • Drug Latanoprost 0.005% Ophthalmic Solution
    Latanoprost 0.005%

Primary outcome measures

  • Change in mean diurnal intraocular pressure (IOP) from baseline [Time frame: 3 months post-treatment initiation]
Secondary outcome measures (2)
  • 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Eye Centers of Southeast Texas — Beaumont

Identifiers

NCT: NCT07465913 · KT-26-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗