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

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ClinicalTrials.gov Identifier: NCT01743729
Recruitment Status : Completed
First Posted : December 6, 2012
Results First Posted : February 24, 2017
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Shire

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
Enrollment 720
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Lifitegrast Placebo
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
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).
Arm/Group Title Lifitegrast Placebo Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 358 360 718
Hide Baseline Analysis Population Description
Randomized population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 358 participants 360 participants 718 participants
58.7  (13.93) 58.9  (14.26) 58.8  (14.09)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 358 participants 360 participants 718 participants
Female
285
  79.6%
265
  73.6%
550
  76.6%
Male
73
  20.4%
95
  26.4%
168
  23.4%
1.Primary Outcome
Title Change From Baseline in Inferior Corneal Fluorescein Staining Score to Day 84
Hide Description Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. The corneal surface is divided into three regions: superior, central and inferior. The scores for each of these 3 regions ranged from 0 to 4 (0=no staining; 1=few/rare punctate lesions; 2=discrete and countable lesions; 3=lesions too numerous to count, but not coalescent; 4=coalescent) with 0.5 point increments, and lower scores indicate improvement. Inferior corneal fluorescein staining scores from the study eye only were reported. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline.
Time Frame Baseline to Day 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) set included all randomized participants who received at least 1 dose of study drug.
Arm/Group Title Lifitegrast Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 358 360
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 2.39  (0.763) 2.40  (0.722)
Change from Baseline to Day 84 -0.73  (0.926) -0.71  (0.943)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lifitegrast, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6186
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment Effect
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.10 to 0.17
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in Eye Dryness Score (Visual Analogue Scale) to Day 84
Hide Description Eye dryness score was assessed on a visual analogue scale (a 7-item [burning/stinging, itching, foreign body sensation, eye discomfort, eye dryness, photophobia, and pain], participant-reported, symptom index) with scores ranging from 0 to 100 (0=no discomfort; 100=maximal discomfort) and lower scores indicate a better outcome.
Time Frame Baseline to Day 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population with last observation carried forward (LOCF).
Arm/Group Title Lifitegrast Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 358 360
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 69.68  (16.954) 69.22  (16.761)
Change from Baseline to Day 84 -35.30  (28.400) -22.75  (28.600)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lifitegrast, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment Effect
Estimated Value 12.61
Confidence Interval (2-Sided) 95%
8.51 to 16.70
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description One participant from placebo group (N=360) has taken study drug by mistake and considered for "Lifitegrast" group (N=358). Therefore, Placebo (N)= 359, Lifitegrast (N)=359 were considered for safety analysis.
 
Arm/Group Title Lifitegrast Placebo
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Lifitegrast Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lifitegrast Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/359 (0.84%)      4/359 (1.11%)    
Ear and labyrinth disorders     
Vertigo * 1  1/359 (0.28%)  1 0/359 (0.00%)  0
Endocrine disorders     
Thyrotoxic crisis * 1  1/359 (0.28%)  1 0/359 (0.00%)  0
Gastrointestinal disorders     
Colitis ischaemic * 1  0/359 (0.00%)  0 1/359 (0.28%)  1
Musculoskeletal and connective tissue disorders     
Osteoarthritis * 1  0/359 (0.00%)  0 1/359 (0.28%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder cancer * 1  0/359 (0.00%)  0 1/359 (0.28%)  1
Renal cancer * 1  1/359 (0.28%)  1 0/359 (0.00%)  0
Nervous system disorders     
Cerebrovascular accident * 1  0/359 (0.00%)  0 1/359 (0.28%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (14.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lifitegrast Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   102/359 (28.41%)      30/359 (8.36%)    
Eye disorders     
Visual acuity reduced * 1  18/359 (5.01%)  23 23/359 (6.41%)  28
General disorders     
Instillation site irritation * 1  28/359 (7.80%)  29 5/359 (1.39%)  5
Instillation site reaction * 1  25/359 (6.96%)  29 4/359 (1.11%)  4
Nervous system disorders     
Dysgeusia * 1  58/359 (16.16%)  58 1/359 (0.28%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (14.1)
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.
If a multicentre publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicentre Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
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
First Submitted: December 3, 2012
First Posted: December 6, 2012
Results First Submitted: August 9, 2016
Results First Posted: February 24, 2017
Last Update Posted: February 24, 2017