Rocklatan vs Latanoprost Post-DSLT

Phase 4RecruitingNCT07465913

Eye Centers of Southeast Texas36 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Glaucoma

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in mean diurnal intraocular pressure (IOP) from baseline

Time frame: 3 months post-treatment initiation

Secondary Outcomes

Change in mean intraocular pressure (IOP) from baseline at each time of day

8am, 12pm, 4pm

Time frame: 3 months post-treatment initiation

Mean percentage decrease in intraocular pressure (IOP) from baseline

Measured using the Snellen chart at each follow-up visit.

Time frame: 3 months post-treatment initiation

Rocklatan vs Latanoprost Post-DSLT

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes