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| Sponsored by: |
Novartis |
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00515424 |
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 I |
| Genetics Home Reference related topics: | early-onset glaucoma |
| MedlinePlus related topics: | Glaucoma High Blood Pressure |
| ChemIDplus related topics: | Latanoprost Tetrahydrozoline Tetrahydrozoline hydrochloride |
| 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 |
Eligibility
| 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.
Contacts and Locations| 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 | |||||
| Novartis |
| Study Chair: | Novartis | Independent Central IRB |
More Information
| Study ID Numbers: | CRKI983A2101 |
| First Received: | August 9, 2007 |
| Last Updated: | December 19, 2007 |
| ClinicalTrials.gov Identifier: | NCT00515424 |
| Health Authority: | United States: Food and Drug Administration |
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