Rocklatan vs Latanoprost Post-DSLT

Purpose

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.

Condition

  • Glaucoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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 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 Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Contralateral eye study
Primary Purpose
Basic Science
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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%

Recruiting Locations

Eye Centers of Southeast Texas
Beaumont, Texas 77707
Contact:
Carol McKee
409-833-0444
cmckee@eyecentersbmt.com

More Details

Status
Recruiting
Sponsor
Eye Centers of Southeast Texas

Study Contact