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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00515424
First Posted: August 13, 2007
Last Update Posted: December 28, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00515424     History of Changes
Other Study ID Numbers: CRKI983A2101
First Submitted: August 9, 2007
First Posted: August 13, 2007
Last Update Posted: December 28, 2007
Last Verified: December 2007

Keywords provided by Novartis:
Glaucoma
Ocular Hypertension
RKI983
Primary Open Angle Glaucoma and Ocular Hypertension

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases