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Efficacy of Ketorolac 0.4% in Prostaglandin Suppression

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ClinicalTrials.gov Identifier: NCT00791323
Recruitment Status : Completed
First Posted : November 14, 2008
Results First Posted : September 23, 2011
Last Update Posted : September 23, 2011
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE November 12, 2008
First Posted Date  ICMJE November 14, 2008
Results First Submitted Date  ICMJE August 17, 2011
Results First Posted Date  ICMJE September 23, 2011
Last Update Posted Date September 23, 2011
Study Start Date  ICMJE November 2008
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2011)
Mean Prostaglandin E2 (PGE2) Aqueous Humor Levels [ Time Frame: Day 3 ]
The mean level of PGE2 (a naturally occurring prostaglandin E2 in the eye that can cause inflammation and other complications) in the aqueous humor (the thin, watery fluid in the eye) 2 days following peripheral iridotomy (ocular surgery).
Original Primary Outcome Measures  ICMJE
 (submitted: November 12, 2008)
Mean PGE2 aqueous levels [ Time Frame: Day 3 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Ketorolac 0.4% in Prostaglandin Suppression
Official Title  ICMJE Not Provided
Brief Summary A pilot study to evaluate the extent of PGE2 inhibition (mean aqueous values) by Ketorolac 0.04% following peripheral iridotomy
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Inflammation
Intervention  ICMJE
  • Drug: Ketorolac 0.4%
    One drop 4 times a day in the pre-operative eye beginning day 0 for 4 days
    Other Name: Acular LS™
  • Drug: Lubricating Eye Drop
    One drop 4 times a day in the operative eye beginning one day prior to the peripheral iridotomy and continuing until the day of IOL implantation
    Other Name: Soothe® XP
Study Arms  ICMJE
  • Active Comparator: 1
    Ketorolac 0.4%
    Intervention: Drug: Ketorolac 0.4%
  • Active Comparator: 2
    Mineral Oil Emollient
    Intervention: Drug: Lubricating Eye Drop
Publications * Not Provided

*   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
Actual Enrollment  ICMJE
 (submitted: September 21, 2011)
9
Original Estimated Enrollment  ICMJE
 (submitted: November 12, 2008)
15
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients scheduled to undergo phakic IOL implantation

Exclusion Criteria:

  • History of intraocular surgery in the operative eye
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00791323
Other Study ID Numbers  ICMJE MA-ACU-08-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Allergan
PRS Account Allergan
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP