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| Sponsor: | Novartis |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00134992 |
Purpose
The objective of this trial was to confirm the tolerability of prednisolone acetate 0.5% eye drops by testing the hypothesis that the ocular safety and tolerability of prednisolone acetate 0.5% eye drops are equivalent to vehicle. Thus healthy volunteers have been selected and have been treated by using a crossover design.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Prednisolone acetate |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Single-Center, Randomized, Double Masked, Two-Period Cross-Over, Three Days Per Period, Phase IV Study to Compare Ocular Safety and Tolerability of Prednisolone Acetate 0.5% Eye Drops Versus Vehicle in Healthy Volunteers |
| Estimated Enrollment: | 30 |
| Study Start Date: | August 2004 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00134992 History of Changes |
| Other Study ID Numbers: | CULT 491 DE 02 |
| Study First Received: | August 24, 2005 |
| Last Updated: | June 7, 2006 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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Prednisolone acetate eye drops tolerability Healthy volunteers |
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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 Antiemetics Central Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents |