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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date † | June 20, 2008 | ||||
| Last Updated Date | June 20, 2008 | ||||
| Start Date † | June 2008 | ||||
| Current Primary Outcome Measures † |
Ocular inflammation [ Time Frame: Day 15 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures † | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures † | |||||
| Original Secondary Outcome Measures † | |||||
| Descriptive Information | |||||
| Brief Title † | Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery | ||||
| Official Title † | |||||
| Brief Summary | Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment | ||||
| Condition † | Cataract Extraction With Intraocular Lens Implantation | ||||
| Intervention † |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 126 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Expanded Access Status | |||||
| Administrative Information | |||||
| NCT ID † | NCT00704418 | ||||
| Responsible Party | Tim McNamara, Vice President Clinical Research & Medical Affairs, ISTA Pharmaceuticals, Inc. | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | ISTA Pharmaceuticals | ||||
| Collaborators †† | |||||
| Investigators † | |||||
| Information Provided By | ISTA Pharmaceuticals | ||||
| Verification Date | June 2008 | ||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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