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Sponsored by: |
Sirion Therapeutics, Inc. |
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Information provided by: | Sirion Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT00616070 |
The purpose of this phase III study is to determine the safety and efficacy of difluprednate in the management of inflammation following ocular surgery.
Condition | Intervention | Phase |
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Inflammation |
Drug: Difluprednate Other: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment |
Estimated Enrollment: | 120 |
Study Start Date: | December 2007 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Difluprednate
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Drug: Difluprednate
Difluprednate
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2: Placebo Comparator
Vehicle
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Other: Placebo
Vehicle
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Ages Eligible for Study: | 2 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
Charlotte Eye, Ear, Nose & Throat | |
Charlotte, North Carolina, United States, 28210 |
Study Chair: | Roger Vogel, MD | Sirion Therapeutics |
Responsible Party: | Sirion Therapeutics ( Roger Vogel, MD ) |
Study ID Numbers: | ST-601-003 |
Study First Received: | February 4, 2008 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00616070 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Inflammation |
Pathologic Processes Inflammation |