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RECRUITINGPhase 4INTERVENTIONAL

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 waiting period after previous treatment 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 Who Should NOT Join This Trial: 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) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Netarsudil ophthalmic solution 0.02%

Apply one drop in each eye every evening

DRUG

Artificial tears

Apply one drop in each eye every evening

Locations (1)

East Coast Institute for Research at Florida Eye Specialists
Jacksonville, Florida, United States