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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Inflammation
Interventions Drug: Ketorolac 0.4%
Drug: Lubricating Eye Drop
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ketorolac 0.4% Soothe® XP
Hide Arm/Group Description Ketorolac 0.4% Mineral Oil Emollient
Period Title: Overall Study
Started 6 3
Completed 6 3
Not Completed 0 0
Arm/Group Title Ketorolac 0.4% Soothe® XP Total
Hide Arm/Group Description Ketorolac 0.4% Mineral Oil Emollient Total of all reporting groups
Overall Number of Baseline Participants 6 3 9
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 3 participants 9 participants
30.2  (9.7) 33.3  (2.5) 31.75  (6.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 3 participants 9 participants
Female
5
  83.3%
1
  33.3%
6
  66.7%
Male
1
  16.7%
2
  66.7%
3
  33.3%
1.Primary Outcome
Title Mean Prostaglandin E2 (PGE2) Aqueous Humor Levels
Hide Description 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).
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat defined as all patients who started the study (randomized) with processed aqueous samples. Two patients in the Ketorolac 0.4% arm did not have aqueous humor samples processed.
Arm/Group Title Ketorolac 0.4% Soothe® XP
Hide Arm/Group Description:
Ketorolac 0.4%
Mineral Oil Emollient
Overall Number of Participants Analyzed 4 3
Mean (Standard Deviation)
Unit of Measure: Picograms per milliliter (pg/ml)
1027.4  (429) 1014.7  (196.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketorolac 0.4% Soothe® XP
Hide Arm/Group Description Ketorolac 0.4% Mineral Oil Emollient
All-Cause Mortality
Ketorolac 0.4% Soothe® XP
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Ketorolac 0.4% Soothe® XP
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/3 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ketorolac 0.4% Soothe® XP
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/3 (0.00%) 
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.
A 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 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vice President Medical Affairs
Organization: Allergan, Inc.
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00791323    
Other Study ID Numbers: MA-ACU-08-001
First Submitted: November 12, 2008
First Posted: November 14, 2008
Results First Submitted: August 17, 2011
Results First Posted: September 23, 2011
Last Update Posted: September 23, 2011