Outcomes of Direct Selective Laser Trabeculoplasty With the Post-treatment Addition of Combination Netarsudil and Latanoprost vs Latanoprost Monotherapy
Eye Centers of Southeast Texas
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…