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

This study has been completed.

First Received on August 9, 2007. Last Updated on December 19, 2007 History of Changes

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

U.S. FDA Resources

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

Charlotte, North Carolina, United States

Durham, North Carolina, United States
United States, Texas

Houston, Texas, United States

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

Independent Central IRB

More Information

No publications provided

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

Keywords provided by Novartis:

Glaucoma
Ocular Hypertension
RKI983
Primary Open Angle Glaucoma and Ocular Hypertension

Additional relevant MeSH terms:

Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension

Eye Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012