Efficacy of Ketorolac 0.4% in Prostaglandin Suppression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00791323
First received: November 12, 2008
Last updated: September 21, 2011
Last verified: September 2011
Results First Received: August 17, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Basic Science
Condition: Inflammation
Interventions: Drug: Ketorolac 0.4%
Drug: Lubricating Eye Drop

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ketorolac 0.4% Ketorolac 0.4%
Soothe® XP Mineral Oil Emollient

Participant Flow:   Overall Study
    Ketorolac 0.4%     Soothe® XP  
STARTED     6     3  
COMPLETED     6     3  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Ketorolac 0.4% Ketorolac 0.4%
Soothe® XP Mineral Oil Emollient
Total Total of all reporting groups

Baseline Measures
    Ketorolac 0.4%     Soothe® XP     Total  
Number of Participants  
[units: participants]
  6     3     9  
Age  
[units: years]
Mean ± Standard Deviation
  30.2  ± 9.7     33.3  ± 2.5     31.75  ± 6.1  
Gender  
[units: participants]
     
Female     5     1     6  
Male     1     2     3  



  Outcome Measures

1.  Primary:   Mean Prostaglandin E2 (PGE2) Aqueous Humor Levels   [ Time Frame: Day 3 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Vice President Medical Affairs
Organization: Allergan, Inc.
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com


No publications provided


Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00791323     History of Changes
Other Study ID Numbers: MA-ACU-08-001
Study First Received: November 12, 2008
Results First Received: August 17, 2011
Last Updated: September 21, 2011
Health Authority: United States: Institutional Review Board