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

This study has been completed.
Information provided by:
Novartis Identifier:
First received: August 9, 2007
Last updated: December 19, 2007
Last verified: December 2007

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
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:

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

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00515424

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
Study Chair: Novartis Independent Central IRB
  More Information

No publications provided 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:
Ocular Hypertension
Primary Open Angle Glaucoma and Ocular Hypertension

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases processed this record on October 02, 2015