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:
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
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.
|Study Start Date:||July 2007|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov 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|