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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).
CompletedPhase 1
Sponsor: Hoffmann-La Roche
Conditions: Glaucoma
Interventions: Latanoprost, Placebo, RO5093151
Countries: United States, Singapore
The purpose of the study is to assess the safety, tolerability, and IOP effects of RO5093151 following 7 days of topical ocular treatment in patients with primary open angle glaucoma or ocular hypertension.
Eligibility overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Locations (7)
- Artesia, California, United States
- Aurora, Colorado, United States
- Morrow, Georgia, United States
- New York, New York, United States
- High Point, North Carolina, United States
- Morgantown, West Virginia, United States
- Singapore, Singapore