Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Novartis |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00515424 |
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: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 90 |
Study Start Date: | July 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
United States, California | |
Artesia, California, United States | |
United States, New York | |
Rochester, New York, United States | |
United States, North Carolina | |
Durham, North Carolina, United States | |
Charlotte, North Carolina, United States | |
United States, Texas | |
Houston, Texas, United States |
Study Chair: | Novartis | Independent Central IRB |
Study ID Numbers: | CRKI983A2101 |
Study First Received: | August 9, 2007 |
Last Updated: | December 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00515424 |
Health Authority: | United States: Food and Drug Administration |
Glaucoma Ocular Hypertension RKI983 Primary Open Angle Glaucoma and Ocular Hypertension |
Glaucoma Eye Diseases Glaucoma, Open-Angle Vascular Diseases |
Tetrahydrozoline Latanoprost Hypertension Ocular Hypertension |
Cardiovascular Diseases |