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 |
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.
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
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New York, New York 10003
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