a study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ro5093151 in patients with primary open angle glaucoma (poag) or ocular hypertension (oht).

Conditions: Glaucoma

Summary: 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 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