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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-29

Study Completion Date

2016-07-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part A

Participants will receive up to 3 multiple ascending dose levels with the starting dose of 0.1% RO5093151 (topical ocular instillation) and sequentially 0.5% and 1% RO5093151 doses or placebo (3:1, active:placebo) twice a day (BID) on Day 1 and once a day (QD) for 6 days.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Matching placebo formulation will be administered in Part A.

RO5093151

Intervention Type DRUG

RO5093151 is a ophthalmic solution, available in dose strengths as 0.1%, 0.5% and 1%.

Part B

Participants will receive highest feasible dose (HFD) or maximum tolerated dose (MTD) of RO5093151 from Part A or 0.005% latanoprost (topical ocular instillation) once daily for 7 days.

Group Type EXPERIMENTAL

Latanoprost

Intervention Type DRUG

Latanoprost is a ophthalmic solution, available in dose strength as 0.005%.

RO5093151

Intervention Type DRUG

RO5093151 is a ophthalmic solution, available in dose strengths as 0.1%, 0.5% and 1%.

Interventions

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Latanoprost

Latanoprost is a ophthalmic solution, available in dose strength as 0.005%.

Intervention Type DRUG

Placebo

Matching placebo formulation will be administered in Part A.

Intervention Type DRUG

RO5093151

RO5093151 is a ophthalmic solution, available in dose strengths as 0.1%, 0.5% and 1%.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No