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| Sponsor: | Novartis |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00170729 |
Purpose
The primary objective was to demonstrate that two days of treatment with 0.5% prednisolone acetate eye-drops after cataract surgery are superior to vehicle in reducing the flare in the anterior chamber of the operated eye.
| Condition | Intervention | Phase |
|---|---|---|
|
Cataract Surgery |
Drug: Prednisolone acetate |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Multi-Center, Randomized, Double Masked, Vehicle Controlled Phase IV Study to Compare the Efficacy, Ocular Safety and Tolerability of a Two Day Treatment With Eye Drops (0.5% Prednisolone Acetate, One Drop Four Times Per Day) in Patients With Intraocular Inflammation After Cataract Surgery, Followed by an Open Label Observational Period of 12 Days |
| Estimated Enrollment: | 60 |
| Study Start Date: | August 2004 |
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Prohibited concomitant medication
Other prohibited conditions
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00170729 History of Changes |
| Other Study ID Numbers: | ULT 491 A DE 01 |
| Study First Received: | September 9, 2005 |
| Last Updated: | June 7, 2006 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Prednisolone acetate, efficacy, cataract, |
eye drops, tolerability, inflammation |
|
Inflammation Uveitis Cataract Pathologic Processes Uveal Diseases Eye Diseases Lens Diseases Tetrahydrozoline Methylprednisolone Methylprednisolone acetate Prednisolone acetate Prednisolone Methylprednisolone Hemisuccinate Prednisolone phosphate Nasal Decongestants |
Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Respiratory System Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents |