A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery
This study has been completed.
Sponsor:
Allergan
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00524264
First received: August 30, 2007
Last updated: September 29, 2009
Last verified: August 2009
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 30, 2007 | ||||
| Last Updated Date | September 29, 2009 | ||||
| Start Date ICMJE | October 2007 | ||||
| Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Resolution of Post Operative Inflammation [ Time Frame: Day 14 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Resolution of post operative inflammation | ||||
| Change History | Complete list of historical versions of study NCT00524264 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | This is a 16-day study to evaluate the safety and efficacy of ketorolac eye drops for the treatment of inflammation and pain associated with cataract surgery. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Drug: ketorolac
Ophthalmic drops, BID pre- and post-operation, and 6 doses on surgery day. Placebo |
||||
| Study Arm (s) |
|
||||
| Publications * | Donnenfeld ED, Nichamin LD, Hardten DR, Raizman MB, Trattler W, Rajpal RK, Alpern LM, Felix C, Bradford RR, Villanueva L, Hollander DA, Schiffman RM. Twice-daily, preservative-free ketorolac 0.45% for treatment of inflammation and pain after cataract surgery. Am J Ophthalmol. 2011 Mar;151(3):420-6.e1. Epub 2010 Dec 9. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 248 | ||||
| Completion Date | April 2008 | ||||
| Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00524264 | ||||
| Other Study ID Numbers ICMJE | 191578-005 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Therapeutic Area Head, Allergan, Inc. | ||||
| Study Sponsor ICMJE | Allergan | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Allergan | ||||
| Verification Date | August 2009 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||