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

Purpose

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.

Condition	Intervention	Phase
Glaucoma Ocular Hypertension	Drug: RKI983	Phase I

Genetics Home Reference related topics:

early-onset glaucoma

MedlinePlus related topics:

Glaucoma High Blood Pressure

ChemIDplus related topics:

Latanoprost Tetrahydrozoline Tetrahydrozoline hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Multicenter, Randomized, Placebo-Controlled, Latanoprost-Controlled, Parallel Group Study to Assess the Tolerability, Safety and Efficacy of RKI983 Ophthalmic Solution Given Twice a Day Over One Week in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension

Further study details as provided by Novartis:

Primary Outcome Measures:

Rates of adverse events and serious adverse events, as well as changes in ophthalmic evaluations, laboratory values, ECGs and vital signs over period of 7 days treatment.

Secondary Outcome Measures:

Change in ocular hypertension from Baseline to Day 7.

Estimated Enrollment:	90
Study Start Date:	July 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

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

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00515424

Locations


United States, California

	Artesia, California, United States

United States, New York

	Rochester, New York, United States

United States, North Carolina

	Durham, North Carolina, United States

	Charlotte, North Carolina, United States

United States, Texas

	Houston, Texas, United States

Sponsors and Collaborators

Novartis

Investigators


Study Chair:	Novartis	Independent Central IRB

More Information

Study ID Numbers:	CRKI983A2101
First Received:	August 9, 2007
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00515424
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Glaucoma

Ocular Hypertension

RKI983

Primary Open Angle Glaucoma and Ocular Hypertension

Study placed in the following topic categories:

Glaucoma

Eye Diseases

Glaucoma, Open-Angle

Vascular Diseases

Tetrahydrozoline

Latanoprost

Hypertension

Ocular Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 29, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00515424