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A Study of RO5093151 in Patients With Ocular Hypertension Or Open Angle Glaucoma

NCT ID: NCT01493271

Last Updated: 2016-11-02

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

PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-11-30

Brief Summary

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This randomized, double-blind, placebo-controlled, multi-center study will evaluate the safety and the effect of RO5093151 on intraocular pressure in patients with ocular hypertension or open angle glaucoma. Patients will be randomized to receive oral doses of RO5093151 or placebo twice daily. The anticipated time on study treatment is 7 days with the possibility to extend to 28 days.

Detailed Description

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Conditions

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Hypertension, Glaucoma, Open-Angle

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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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to RO5093151

RO5093151

Group Type EXPERIMENTAL

RO5093151

Intervention Type DRUG

oral doses twice daily for up to 28 days

Interventions

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Placebo

Placebo to RO5093151

Intervention Type DRUG

RO5093151

oral doses twice daily for up to 28 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients, at least 21 years of age, inclusive
* Diagnosis of ocular hypertension or primary open angle glaucoma in at least one eye
* Able to participate and willing to give informed consent

Exclusion Criteria

* Presence of extreme narrow angle with complete or partial closure
* Progressive retinal or optic nerve disease from any cause other than glaucoma
* History or signs of penetrating ocular trauma
* Uncontrolled hypertension
* Clinically significant abnormalities in laboratory test results
* Positive test results on hepatitis B, hepatitis C, or HIV 1 and 2
* Kidney disease or dysfunction
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Morrow, Georgia, United States

Site Status

High Point, North Carolina, United States

Site Status

Mt. Pleasant, South Carolina, United States

Site Status

Sofia, , Bulgaria

Site Status

Hradec Králové, , Czechia

Site Status

Litomysi, , Czechia

Site Status

Prague, , Czechia

Site Status

Ústí nad Labem, , Czechia

Site Status

Zlín, , Czechia

Site Status

Budapest, , Hungary

Site Status

Budapest, , Hungary

Site Status

Esztergom, , Hungary

Site Status

Countries

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United States Bulgaria Czechia Hungary

Other Identifiers

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BP25466

Identifier Type: -

Identifier Source: org_study_id