Effect of Rhopressa on Intraocular Pressure (IOP) in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension Post-SLT

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)

The purpose of this study is to collect data about how Rhopressa affects IOP in patients who have had an SLT procedure in both eyes.

Study Overview

• Status: Recruiting
• Conditions: Primary Open Angle Glaucoma or Ocular Hypertension
• Intervention / Treatment: Drug: Netarsudil ophthalmic solution 0.02%; Drug: Artificial tears

Detailed Description

This is a prospective, randomized, double-masked, placebo controlled (artificial tears), single center study. The study population will include seventy (n=70) subjects with POAG or ocular hypertension who have undergone SLT and may benefit from additional IOP reduction. If individuals are a candidate for treatment with Rhopressa (netarsudil) 0.02% ophthalmic solution post-SLT, they can potentially be included in the trial. The study duration per subject is expected to be 6 weeks (or up to 12 weeks if washout is required for previous IOP lowering treatment) with three scheduled study visits.

While both Rhopressa and 360 degrees SLT primarily target the trabecular meshwork, potential synergistic effects of the two therapies on conventional aqueous outflow are not completely understood. This study will determine whether initiation of Rhopressa post-360 degrees SLT provides greater IOP reduction than 360 degrees SLT alone. This information will aid healthcare providers in selecting the best approach to management of IOP in patients who have recently undergone 360 degrees SLT and may benefit from additional IOP reduction.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Rebecca Goldfaden, PharmD; Phone Number: 904-267-1584; Email: rg@eastcoastresearch.net

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Recruiting
      • East Coast Institute for Research at Florida Eye Specialists
      • Principal Investigator: Rajesh Shetty, MD
      • Contact: Kaitlyn Click, COA, CCMA; Phone Number: 904-267-1584; Email: kaitlyn.click@eastcoastresearch.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rhopressa	Drug: Netarsudil ophthalmic solution 0.02%; Apply one drop in each eye every evening; Other Names: Rhopressa
Placebo Comparator: Artificial Tears	Drug: Artificial tears; Apply one drop in each eye every evening

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean diurnal intraocular pressure (IOP)	Between-group difference in change in mean diurnal IOP	42 Days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular pressure (IOP) reduction at 8am, 10am, and 4pm	Between-group difference in change in IOP at the 8am, 10am, and 4pm timepoints	42 Days

Collaborators and Investigators

• Sponsor: East Coast Institute for Research
• Collaborators: Alcon, a Novartis Company; Florida Eye Specialists

Publications and helpful links

General Publications

• Kass MA, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP, Parrish RK 2nd, Wilson MR, Gordon MO. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002 Jun;120(6):701-13; discussion 829-30. doi: 10.1001/archopht.120.6.701.
• Stuart, Annie. "Drug Update: Vyzulta and Rhopressa." Glaucoma Clinical Update, 31 Aug. 2018.
• Zaman F, Gieser SC, Schwartz GF, Swan C, Williams JM. A multicenter, open-label study of netarsudil for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension in a real-world setting. Curr Med Res Opin. 2021 Jun;37(6):1011-1020. doi: 10.1080/03007995.2021.1901222. Epub 2021 Mar 27.
• Allison K, Patel D, Alabi O. Epidemiology of Glaucoma: The Past, Present, and Predictions for the Future. Cureus. 2020 Nov 24;12(11):e11686. doi: 10.7759/cureus.11686.
• Gazzard G, Konstantakopoulou E, Garway-Heath D, Garg A, Vickerstaff V, Hunter R, Ambler G, Bunce C, Wormald R, Nathwani N, Barton K, Rubin G, Buszewicz M; LiGHT Trial Study Group. Selective laser trabeculoplasty versus eye drops for first-line treatment of ocular hypertension and glaucoma (LiGHT): a multicentre randomised controlled trial. Lancet. 2019 Apr 13;393(10180):1505-1516. doi: 10.1016/S0140-6736(18)32213-X. Epub 2019 Mar 9.

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: March 4, 2025
• First Submitted That Met QC Criteria: March 4, 2025
• First Posted (Actual): March 7, 2025

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: June 27, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: POAG; ocular hypertension; primary open angle glaucoma; SLT; Selective Laser Trabeculoplasty; netarsudil; Rhopressa
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Eye Diseases; Hypertension; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Pharmaceutical Solutions; Lubricant Eye Drops; Ophthalmic Solutions
• Other Study ID Numbers: ECIR-Alcon-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Only IPD used in the results publication
• IPD Sharing Time Frame: When the trial starts until it ends data collection
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No