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

Korábbi kezelés

• 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)
• Previous or currently active corneal disease that, in the opinion of the investigator, could affect the study outcomes
• 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.

Más betegség

• Any condition that prevents reliable applanation tonometry in either eye (e.g., significant corneal surface abnormalities, scars, keratoconus)
• 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)
• Any condition in the opinion of the investigator that would potentially confound the results of this study

Egyéb

• Advanced stage of glaucoma, as determined by the investigator based on medical record review

• 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