RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2025-06-27

Study Completion:2026-04-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06865144

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Rebecca Goldfaden, PharmD

CONTACT

904-267-1584

rg@eastcoastresearch.net

Study Locations (Sites)

East Coast Institute for Research at Florida Eye Specialists

Jacksonville, Florida, 32256

United States

Collaborators and Investigators

Sponsor: East Coast Institute for Research

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-27

Study Completion Date2026-04-01

Study Record Updates

Study Start Date2025-06-27

Study Completion Date2026-04-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Primary Open Angle Glaucoma or Ocular Hypertension