Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01010633
First received: November 6, 2009
Last updated: December 8, 2011
Last verified: December 2011
Results First Received: August 30, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Inflammation
Pain
Interventions: Drug: Vehicle of Loteprednol Etabonate
Drug: Loteprednol Etabonate

  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
This study was initiated at 20 clinics in the United States (US). Three sites did not enroll any participants. The study was conducted at the remaining 17 sites. First participant was enrolled 11/23/2009 and last participant completed 6/25/2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
406 participants eligible for cataract surgery were enrolled in the study (safety population). 397 participants completed the study.

Reporting Groups
  Description
Loteprednol Loteprednol etabonate 0.5%
Vehicle Vehicle of loteprednol etabonate

Participant Flow:   Overall Study
    Loteprednol     Vehicle  
STARTED     203     203  
COMPLETED     199     198  
NOT COMPLETED     4     5  
Adverse Event                 1                 1  
Protocol Violation                 1                 2  
Withdrawal by Subject                 2                 1  
Investigator decision                 0                 1  



  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
Loteprednol Loteprednol etabonate 0.5%
Vehicle Vehicle of loteprednol etabonate
Total Total of all reporting groups

Baseline Measures
    Loteprednol     Vehicle     Total  
Number of Participants  
[units: participants]
  203     203     406  
Age  
[units: years]
Mean ± Standard Deviation
  69.3  ± 8.73     69.0  ± 9.80     69.1  ± 9.27  
Gender  
[units: participants]
     
Female     109     122     231  
Male     94     81     175  
Race/Ethnicity, Customized  
[units: participants]
     
American Indian or Alaska Native     0     1     1  
Asian     2     3     5  
Native Hawaiian or Other Pacific Islander     1     0     1  
Black or African American     20     16     36  
White     176     182     358  
Other     4     1     5  



  Outcome Measures
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1.  Primary:   Resolution of Anterior Chamber Cells (ACC).   [ Time Frame: Visit 5 (Postoperative day 8) ]

2.  Primary:   Grade 0 Pain   [ Time Frame: Visit 5 (Postoperative Day 8) ]

3.  Secondary:   Resolution of Anterior Chamber Cells.   [ Time Frame: At visits 4-7- postoperative day 3, 8,15 & 18 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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.


Results Point of Contact:  
Name/Title: Tuyen Ong, MD, MRCOphth
Organization: Bausch & Lomb Incorporated
phone: (973) 360-6389
e-mail: tuyen.ong@bausch.com


No publications provided by Bausch & Lomb Incorporated

Publications automatically indexed to this study:

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01010633     History of Changes
Other Study ID Numbers: 576
Study First Received: November 6, 2009
Results First Received: August 30, 2011
Last Updated: December 8, 2011
Health Authority: United States: Food and Drug Administration