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NCT Number: NCT07465913

Rocklatan vs Latanoprost Post-DSLT

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Eye Centers of Southeast Texas

Beaumont, Texas, 77707, United States

Location status: Recruiting

Location contact

Carol McKee

CONTACT

[email protected]

409-833-0444

Kevin Talbot, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rocklatan 0.02%-0.005% Ophthalmic Solution

Drug

netarsudil and latanoprost 0.02%/0.005%

Latanoprost 0.005% Ophthalmic Solution

Drug

Latanoprost 0.005%

Primary outcomes

  1. Change in mean diurnal intraocular pressure (IOP) from baseline

    Time frame: 3 months post-treatment initiation

Secondary outcomes

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

    Time frame: 3 months post-treatment initiation

    8am, 12pm, 4pm

  2. Mean percentage decrease in intraocular pressure (IOP) from baseline

    Time frame: 3 months post-treatment initiation

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

Sponsors and collaborators

Lead sponsor

Eye Centers of Southeast Texas

Other

Collaborators

  • Sengi

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 12, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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