Rhopressa after 360° SLT to lower eye pressure in glaucoma or ocular hypertension

Prospective, Randomized, Double- Masked Study to Evaluate the Effect of Rhopressa Versus Placebo on Intraocular Pressure (IOP) in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension Post-Selective Laser Trabeculoplasty (SLT)

This trial will test whether Rhopressa (netarsudil) eye drops lower intraocular pressure more than artificial tears in people with primary open-angle glaucoma or ocular hypertension who recently had 360° SLT in both eyes.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: East Coast Institute for Research (Research network)
• Locations: 1 site (Jacksonville, Florida)
• Trial ID: NCT06865144 on ClinicalTrials.gov

What this trial studies

This is a prospective, randomized, double-masked, placebo-controlled, single-center trial enrolling 70 subjects with bilateral primary open-angle glaucoma or ocular hypertension who completed 360° selective laser trabeculoplasty (SLT) within the prior 90 days. Participants are randomized to netarsudil 0.02% ophthalmic solution (Rhopressa) or artificial tears and followed with three scheduled in-person visits over approximately 6 weeks (up to 12 weeks if a washout of prior medications is required). The primary goal is to compare mean diurnal intraocular pressure reduction in the eye designated for the study intervention between the netarsudil and control arms. The trial will determine whether initiating netarsudil after full 360° SLT provides additional IOP lowering beyond SLT alone.

Who should consider this trial

Good fit: Adults (≥18 years) with documented bilateral primary open-angle glaucoma or ocular hypertension who completed 360° SLT in both eyes within the last 90 days, have mean diurnal IOP of 16–28 mmHg at randomization, and are judged by the investigator to be candidates for netarsudil are eligible.

Not a fit: Patients whose IOP is already controlled outside the study range, who are not candidates for netarsudil, who cannot attend the Jacksonville, FL visits, or who have contraindications to the drug are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, adding Rhopressa after 360° SLT could provide additional IOP reduction and reduce the need for further interventions or medications.

How similar studies have performed: Both netarsudil and SLT have independently been shown to lower IOP in prior studies, but randomized data specifically testing netarsudil initiated after 360° SLT are limited.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years
2. Documented diagnosis of bilateral POAG or ocular hypertension as determined by the investigator based on medical record review.
3. At Screening (V1), the subject completed SLT in both the eyes within the last 90 days.
4. Mean diurnal IOP of 16 to 28 mmHg at Randomization (V2 )
5. At Randomization (V2), in the opinion of the investigator, subject may benefit from additional IOP reduction in the study eye and is a candidate for treatment with Rhopressa
6. At Randomization (V2), if treated with IOP-lowering medication(s) in either eye prior to SLT, subject has completed the minimum washout period for the medication(s) (see Table 1)
7. If female, subject is either incapable of pregnancy (e.g., history of bilateral oophorectomy, hysterectomy, bilateral tubal ligation) or post-menopausal (amenorrheic for at least 2 years) or will use an effective (e.g., double barrier) method of birth control for the duration of the study

Exclusion Criteria:

1. History of more than one treatment with SLT in either eye
2. Unable or unwilling to discontinue current IOP-lowering medication(s), if applicable
3. Prior or current treatment with a rho kinase inhibitor
4. Prior microinvasive glaucoma surgery (MIGS)
5. Advanced stage of glaucoma, as determined by the investigator based on medical record review
6. Any condition that prevents reliable applanation tonometry in either eye (e.g., significant corneal surface abnormalities, scars, keratoconus)
7. Previous or currently active corneal disease that, in the opinion of the investigator, could affect the study outcomes
8. Active or recurrent intraocular infection, inflammation, iritis or uveitis
9. Retinal disease (e.g., diabetic retinopathy, macular degeneration, central retinal vein or artery occlusion, macular edema)
10. Intraocular injection performed ≤ 6 months prior to Screening (V1)
11. Anticipated use of any topical ocular steroids and/or topical ocular nonsteroidal anti-inflammatory drugs (NSAID) during the study period
12. Current participation in any drug or device clinical investigation, receipt of investigational drug within 6 drug half-lives of Screening (V1), or any previous placement of an investigational device.
13. Any condition in the opinion of the investigator that would potentially confound the results of this study

Where this trial is running

Jacksonville, Florida

• East Coast Institute for Research at Florida Eye Specialists — Jacksonville, Florida, United States (Recruiting)

Study contacts

• Study coordinator: Rebecca Goldfaden, PharmD

Conditions Primary Open Angle Glaucoma or Ocular Hypertension; primary open angle glaucoma; ocular hypertension; SLT; POAG; Selective Laser Trabeculoplasty; Rhopressa; netarsudil