A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5093151 in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).



Status:Completed
Conditions:High Blood Pressure (Hypertension), Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:December 29, 2015
End Date:July 28, 2016

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A MULTIPLE-CENTER, INVESTIGATOR/SUBJECT MASKED, ADAPTIVE, MULTIPLE ASCENDING DOSE, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF RO5093151 FOLLOWING 7 DAYS ADMINISTRATION IN PATIENTS WITH PRIMARY OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION

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.


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
We found this trial at
7
sites
Artesia, California 90701
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Artesia, CA
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1675 Aurora Court
Aurora, Colorado 80045
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Aurora, CO
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High Point, North Carolina 27262
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High Point, NC
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Morgantown, West Virginia 26506
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Morgantown, WV
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Morrow, GA
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New York, NY
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Singapore,
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