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Safety Study of Lifitegrast to Treat Dry Eye (SONATA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01636206
First Posted: July 10, 2012
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shire
Results First Submitted: August 9, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Dry Eye
Interventions: Drug: Lifitegrast
Drug: Placebo

  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
Placebo No text entered.
Lifitegrast No text entered.

Participant Flow:   Overall Study
    Placebo   Lifitegrast
STARTED   111   221 
COMPLETED   92   170 
NOT COMPLETED   19   51 



  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.
Randomized population.

Reporting Groups
  Description
Placebo No text entered.
Lifitegrast No text entered.
Total Total of all reporting groups

Baseline Measures
   Placebo   Lifitegrast   Total 
Overall Participants Analyzed 
[Units: Participants]
 111   221   332 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.0  (13.18)   58.8  (12.39)   59.5  (12.68) 
Gender 
[Units: Participants]
Count of Participants
     
Female      85  76.6%      165  74.7%      250  75.3% 
Male      26  23.4%      56  25.3%      82  24.7% 


  Outcome Measures

1.  Primary:   Number of Participants With Ocular and Nonocular Treatment Emergent Adverse Events (TEAEs) for 1 Year   [ Time Frame: Day 0 to Day 360 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
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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: Study Physician
Organization: Shire
phone: 1866-842-5335



Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01636206     History of Changes
Other Study ID Numbers: 1118-DRY-400
First Submitted: July 5, 2012
First Posted: July 10, 2012
Results First Submitted: August 9, 2016
Results First Posted: October 3, 2016
Last Update Posted: February 23, 2017