Clareo Health | A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5093151 in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5093151 in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).
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–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of ocular hypertension (OHT) or primary open angle glaucoma (POAG) in at least one eye (qualifying eye) as determined by the Investigator at screening or based on a reliable and documented assessment done within the last 6 months prior to screening provided that no progression of visual field damage is expected
At baseline visit, intraocular pressure (IOP) \>= 24 mmHg in the morning and \>= 21 mmHg in the afternoon measurement in at least one eye (qualifying eye = study eye) and =\< 34 mmHg at all time points in both eyes
Best corrected logMAR visual acuity score of 0.7 (20/100 Snellen) or better in each eye as measured by ETDRS visual acuity test at screening
Central corneal pachymetry measurement 420 to 620 micrometer in qualifying eye at screening
Cup-to-disk ratio =\< 0.8 (both eyes) at screening
Anterior chamber angle is open and non-occludable as confirmed by the Investigator by gonioscopy examination at screening
You may not be if
History of any clinically significant gastrointestinal, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease (multiple allergies, seasonal allergy is acceptable), metabolic disorder, cancer or cirrhosis
Uncontrolled hypertension (SBP \>= 160 mmHg and/or DBP \>= 100 mmHg) despite treatment at the time of screening confirmed by the average of \>= 3 blood pressure measurements, properly measured with well-maintained equipment
Clinically significant abnormalities in laboratory test results at screening
Hypersensitivity to RO5093151 or any of the components of its formulation, or hypersensitivity to latanoprost or any of the components of its formulation (Part B only)
Donation of blood over 500 mL within three months prior to screening
Positive result on hepatitis B (HBV), hepatitis C (HCV), or HIV 1 and 2
Presence of narrow angle (=\< grade 2 Shaffer gonioscopic classification) or complete or partial closure, as measured by gonioscopy or at risk for angle closure as assessed by the Investigator
Other forms of glaucoma than POAG or OHT in the study eye
Any abnormality preventing reliable applanation tonometry
Any clinically significant corneal scarring, haze or opacity
Patient uncooperativeness that restricts adequate examination of IOP, ocular fundus or anterior chamber
Evidence of clinically significant blepharitis, concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis
History or signs of penetrating ocular trauma. Uneventful (uncomplicated) cataract surgery performed 3 months prior to screening is allowed
According to the Investigator's best judgment, risk of visual field or visual acuity worsening in either eye as a consequence of glaucoma progression or consequence of participation in the trial (i.e., during washout of ocular hypotensive medications or treatment with placebo) or any other ocular disease
Unable to safely stop ocular hypotension medications prior to randomization according to the required minimum washout periods
History of any ocular filtering surgical intervention, previous glaucoma intraocular surgery, or laser trabeculoplasty
History of refractive surgery (laser assisted in-situ keratomileusis, laser epithelial keratomileusis, photorefractive keratectomy, phototherapeutic keratectomy)
Any other intraocular surgery within 6 months of screening
Advanced age-related macular degeneration (wet or dry), vitreous hemorrhage, diabetic retinopathy or any progressive retinal or optic nerve disease from any cause other than glaucoma
