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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:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00515424
First received: August 9, 2007
Last updated: December 19, 2007
Last verified: December 2007
History of Changes
  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
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:

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 May 22, 2013