Recruiting

DSLT with Rocklatan

Sponsor:

Eye Centers of Southeast Texas

Code:

NCT07465913

Conditions

Glaucoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rocklatan 0.02%-0.005% Ophthalmic Solution

Latanoprost 0.005% Ophthalmic Solution

Study Details

Brief 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.

Conditions

Glaucoma

Study ID

NCT07465913

Start date

May 14, 2026

Status verified date

May, 2026

Completion date

May 6, 2027

Anticipated

Primary completion date

May 6, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Rocklatan

netarsudil and latanoprost 0.02%/0.005%

active comparator: Lantanoprost

0.005%

Interventions

Rocklatan 0.02%-0.005% Ophthalmic Solution

netarsudil and latanoprost 0.02%/0.005%

Latanoprost 0.005% Ophthalmic Solution

Latanoprost 0.005%

Primary outcome measure

  • Change in mean diurnal intraocular pressure (IOP) from baseline [ Time Frame: 3 months post-treatment initiation ]

Central Contacts and Locations

Locations

Eye Centers of Southeast Texas

Recruiting

Beaumont, Texas, United States, 77707

Contacts

Carol McKee

409-833-0444cmckee@eyecentersbmt.com

Principal Investigator:

Kevin Talbot, MD

More Information

Sponsor

Eye Centers of Southeast Texas

Last update posted

May 22, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eye Centers of Southeast Texas on 2026-05-22.