Rocklatan vs Latanoprost Post-DSLT

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Rocklatan 0.02%-0.005% Ophthalmic Solution
  netarsudil and latanoprost 0.02%/0.005%
• Препарат Latanoprost 0.005% Ophthalmic Solution
  Latanoprost 0.005%

Первичные конечные точки

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

Вторичные конечные точки (2)

• Change in mean intraocular pressure (IOP) from baseline at each time of day [Срок оценки: 3 months post-treatment initiation]
• Mean percentage decrease in intraocular pressure (IOP) from baseline [Срок оценки: 3 months post-treatment initiation]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Eye Centers of Southeast Texas — Beaumont

Идентификаторы

NCT: NCT07465913 · KT-26-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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