A Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7058584 Following 7 Days of Instillation of Eye Drops in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–90
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
18 to 90 years of age inclusive, at the time of signing the informed consent form
Confirmed diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG) in both eyes as determined by the investigator at screening
Treatment-naïve participants or participants who are able to safely stop their Intraocular pressure (IOP)-lowering medication(s) prior to randomization according to the required minimum washout periods
At baseline visit, IOP ≥ 24 millimeters of mercury (mmHg) in the morning (8:00 AM ± 1h) and ≥ 22 mmHg in the afternoon (2:00 PM ± 1h) measurement in the same eye and ≤ 34 mmHg at all timepoints in both eyes
Best corrected logarithm of the minimum angle of resolution (logMAR) visual acuity score of 0.7 or better in each eye as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity test at screening
Central corneal thickness (pachymetry) measurement 450 to 620 micrometers (μm) in both eyes at screening
Cup-to-disc ratio ≤ 0.8 (both eyes) at screening
Anterior chamber angle is open and non-occludable (both eyes) as confirmed by the investigator by gonioscopy examination at screening
You may not be if
Advanced visual field defects
Other forms of glaucoma than POAG or OHT
Any abnormality preventing reliable applanation tonometry
Any clinically significant corneal scarring, haze or opacity
Uncooperativeness of the participant that restricts adequate examination of IOP, ocular fundus or anterior chamber
Any presence or history of uveitis or other history of any ocular inflammatory disease.
History or signs of penetrating ocular trauma
Risk of visual field or visual acuity worsening in either eye as a consequence of glaucoma progression or consequence of participation in the trial or any other ocular disease, according to the investigator's best judgment
History of any glaucoma surgery
History of refractive surgery
Any other intra-ocular surgery within six months of screening
Any active ocular disease requiring treatment.
Use of any listed prohibited medications
Current enrollment or past participation within the last 30 days before the screening visit in any other clinical study involving an investigational study treatment or any other type of medical research
Any participant who is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff thereof, directly involved in the conduct of the protocol
Clareo Health | A Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7058584 Following 7 Days of Instillation of Eye Drops in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
