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

Launched by EAST COAST INSTITUTE FOR RESEARCH · Mar 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how a medication called Rhopressa affects eye pressure in patients who have primary open-angle glaucoma or ocular hypertension after having a specific treatment called selective laser trabeculoplasty (SLT) in both eyes. The main goal is to see if Rhopressa can help lower eye pressure even more for those who have already had the SLT procedure.

To participate in this trial, you need to be at least 18 years old and have been diagnosed with glaucoma or ocular hypertension in both eyes. You should have completed the SLT treatment within the last 90 days and have a specific range of eye pressure at the time of screening. Additionally, if you are a woman, you should either be unable to become pregnant or agree to use effective birth control during the study. Participants will be monitored to see how well Rhopressa works and if it helps reduce eye pressure effectively. This study is not currently recruiting participants, but it aims to provide important information about treatment options for managing eye pressure in glaucoma patients.

Gender

ALL

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