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Tolerability, Safety and Efficacy of RKI983 Eye Drops in Subjects With Primary Open Angle Glaucoma and Ocular Hypertension

NCT ID: NCT00515424

Last Updated: 2007-12-28

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Brief Summary

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This study will evaluate the tolerability and safety of RKI983 ophthalmic solution and explore the effect of the compound on intraocular pressure in subjects with ocular hypertension.

Detailed Description

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Conditions

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Glaucoma Ocular Hypertension

Keywords

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Glaucoma Ocular Hypertension RKI983 Primary Open Angle Glaucoma and Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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RKI983

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males and females, ≥18 years of age, with primary open angle glaucoma and ocular hypertension
* Females must be post-menopausal or surgically sterile

Exclusion Criteria

* Other types of glaucoma
* Eye pressure lowering surgeries
* A history of or current eye conditions or medical problems that would prohibit the use of an investigational drug
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis

Role: STUDY_CHAIR

Independent Central IRB

Locations

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Artesia, California, United States

Site Status

Rochester, New York, United States

Site Status

Charlotte, North Carolina, United States

Site Status

Durham, North Carolina, United States

Site Status

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CRKI983A2101

Identifier Type: -

Identifier Source: org_study_id