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A Phase 3 Study to Evaluate the Efficacy of Lifitegrast in Subjects With Dry Eye

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01743729
First received: December 3, 2012
Last updated: January 5, 2017
Last verified: January 2017
Results First Received: August 9, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (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
Two of 720 participants were excluded from data analysis due to duplication. Therefore, 718 participants were randomized and treated. One participant from placebo arm (N=360) has taken study drug by mistake and considered for "Lifitegrast" arm (N=358). Therefore, Placebo (N=359), Lifitegrast (N=359) were considered for safety analysis.

Reporting Groups
  Description
Lifitegrast No text entered.
Placebo No text entered.

Participant Flow:   Overall Study
    Lifitegrast   Placebo
STARTED   358 [1]   360 [2] 
COMPLETED   321   348 
NOT COMPLETED   37   12 
[1] One participant from placebo arm included in Lifitegrast arm for safety analysis set (N=359).
[2] One placebo participant was considered for Lifitegrast arm; Placebo safety analysis set (N= 359).



  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
Lifitegrast No text entered.
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
   Lifitegrast   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 358   360   718 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.7  (13.93)   58.9  (14.26)   58.8  (14.09) 
Gender 
[Units: Participants]
Count of Participants
     
Female      285  79.6%      265  73.6%      550  76.6% 
Male      73  20.4%      95  26.4%      168  23.4% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Inferior Corneal Fluorescein Staining Score to Day 84   [ Time Frame: Baseline to Day 84 ]

2.  Primary:   Change From Baseline in Eye Dryness Score (Visual Analogue Scale) to Day 84   [ Time Frame: Baseline to Day 84 ]


  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
No text entered.


  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: NCT01743729     History of Changes
Other Study ID Numbers: 1118-DRY-300
Study First Received: December 3, 2012
Results First Received: August 9, 2016
Last Updated: January 5, 2017