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

NCT06865144 | Recruiting Phase 4 FDA Drug

• 1 other identifier: ECIR-Alcon-02
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Open Angle Glaucoma or Ocular Hypertension

Keywords

primary open angle glaucoma; ocular hypertension; SLT; POAG; Selective Laser Trabeculoplasty; Rhopressa; netarsudil

Outcome Measures

Primary Outcomes (1)

• Mean diurnal intraocular pressure (IOP)

  Between-group difference in change in mean diurnal IOP

  42 Days

Other Outcomes (1)

• Intraocular pressure (IOP) reduction at 8am, 10am, and 4pm

  42 Days

Study Arms (2)

Rhopressa

EXPERIMENTAL

Drug: Netarsudil ophthalmic solution 0.02%

Artificial Tears

PLACEBO COMPARATOR

Drug: Artificial tears

Interventions

Netarsudil ophthalmic solution 0.02% DRUG

Apply one drop in each eye every evening

Also known as: Rhopressa

Rhopressa

Artificial tears DRUG

Apply one drop in each eye every evening

Artificial Tears

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Documented diagnosis of bilateral POAG or ocular hypertension as determined by the investigator based on medical record review.
• At Screening (V1), the subject completed SLT in both the eyes within the last 90 days.
• Mean diurnal IOP of 16 to 28 mmHg at Randomization (V2 )
• 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
• 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)
• 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

You may not qualify if:

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

Sponsors & Collaborators

• East Coast Institute for Research: lead
• Alcon, a Novartis Company: collaborator
• Florida Eye Specialists: collaborator

Study Sites (1)

East Coast Institute for Research at Florida Eye Specialists

Jacksonville, Florida, 32256, United States

RECRUITING

Related Publications (5)

• Stuart, Annie. "Drug Update: Vyzulta and Rhopressa." Glaucoma Clinical Update, 31 Aug. 2018.

  BACKGROUND

• 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.

  PMID: 33733980 BACKGROUND

• 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.

  PMID: 30862377 BACKGROUND

• 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.

  PMID: 12049574 BACKGROUND

• 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.

  PMID: 33391921 BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Central Study Contacts

Rebecca Goldfaden, PharmD

CONTACT

904-267-1584; rg@eastcoastresearch.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 7, 2025
• Study Start: June 27, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: When the trial starts until it ends data collection

Locations

US (1)