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A Study to Evaluate Efficacy and Safety of Lifitegrast in Subjects With Dry Eye (OPUS-3) (OPUS-3)

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ClinicalTrials.gov Identifier: NCT02284516
Recruitment Status : Completed
First Posted : November 6, 2014
Results First Posted : March 15, 2017
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Dry Eye Disease
Interventions Drug: Lifitegrast
Drug: Placebo
Enrollment 711
Recruitment Details  
Pre-assignment Details Two participants from placebo arm (N=356) has taken study drug by mistake and considered for "Lifitegrast" arm (N=355). Therefore, Placebo (N=354), Lifitegrast (N=357) were considered for safety analysis.
Arm/Group Title Placebo Lifitegrast
Hide Arm/Group Description Placebo ophthalmic solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days. Lifitegrast 5% Ophthalmic Solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
Period Title: Overall Study
Started 356 355
Safety Population 354 [1] 357 [2]
Completed 318 319
Not Completed 38 36
[1]
Two placebo participants were considered for Lifitegrast arm; Placebo safety analysis set (N= 354).
[2]
Two placebo participants were included in Lifitegrast arm for safety analysis set (N=357).
Arm/Group Title Placebo Lifitegrast Total
Hide Arm/Group Description Placebo ophthalmic solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days. Lifitegrast 5% Ophthalmic Solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days. Total of all reporting groups
Overall Number of Baseline Participants 356 355 711
Hide Baseline Analysis Population Description
Randomized population included all participants screened for whom a randomization number was assigned.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 356 participants 355 participants 711 participants
58.6  (14.84) 58.8  (14.10) 58.7  (14.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 356 participants 355 participants 711 participants
Female
269
  75.6%
268
  75.5%
537
  75.5%
Male
87
  24.4%
87
  24.5%
174
  24.5%
1.Primary Outcome
Title Change From Baseline in Patient-Reported Eye Dryness Score to Day 84
Hide Description Eye dryness score was scored on a Visual Analogue Scale (VAS) ranges from 0-100 (0=no discomfort; 100=maximal discomfort).
Time Frame Baseline to Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population included all randomized participants who took at least 1 dose of investigational product with last observation carried forward (LOCF). Here, n = number of participants analyzed for the specific categories of each arm, respectively.
Arm/Group Title Placebo Lifitegrast
Hide Arm/Group Description:
Placebo ophthalmic solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
Lifitegrast 5% Ophthalmic Solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
Overall Number of Participants Analyzed 356 355
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=356, 355) 69.0  (17.08) 68.3  (16.88)
Change from Baseline to Day 84 (n=353, 353) -30.7  (28.01) -37.9  (28.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lifitegrast
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.0007
Comments The primary analysis was performed using a stratified 2-sample t-test (that is, analysis of variance [ANOVA]).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment Effect
Estimated Value 7.16
Confidence Interval (2-Sided) 95%
3.04 to 11.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.096
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Patient-Reported Eye Dryness Score to Day 14 and Day 42
Hide Description Eye dryness score was scored on a Visual Analogue Scale (VAS) ranges from 0-100 (0=no discomfort; 100=maximal discomfort).
Time Frame Baseline to Day 14 and Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population with LOCF. Here, n = number of participants analyzed for the specific categories of each arm, respectively.
Arm/Group Title Placebo Lifitegrast
Hide Arm/Group Description:
Placebo ophthalmic solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
Lifitegrast 5% Ophthalmic Solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
Overall Number of Participants Analyzed 356 355
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=356, 355) 69.0  (17.08) 68.3  (16.88)
Change from Baseline to Day 14 (n=353, 352) -15.0  (22.40) -22.9  (25.44)
Change from Baseline to Day 42 (n=353, 353) -23.9  (25.99) -33.2  (27.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lifitegrast
Comments Baseline and Day 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The primary analysis was performed using a stratified 2-sample t-test (that is, analysis of variance [ANOVA]).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment Effect
Estimated Value 7.85
Confidence Interval (2-Sided) 95%
4.33 to 11.37
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.792
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lifitegrast
Comments Baseline and Day 42
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The primary analysis was performed using a stratified 2-sample t-test (that is, analysis of variance [ANOVA]).
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment Effect
Estimated Value 9.32
Confidence Interval (2-Sided) 95%
5.44 to 13.20
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.976
Estimation Comments [Not Specified]
Time Frame From start of the study drug administration upto Day 91 or Early termination (ET)
Adverse Event Reporting Description Two participants from placebo arm (N=356) has taken study drug by mistake and considered for "Lifitegrast" arm (N=355). Therefore, Placebo (N=354), Lifitegrast (N=357) were considered for safety analysis.
 
Arm/Group Title Placebo Lifitegrast
Hide Arm/Group Description Placebo ophthalmic solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days. Lifitegrast 5% Ophthalmic Solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
All-Cause Mortality
Placebo Lifitegrast
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Lifitegrast
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/354 (1.13%)      4/357 (1.12%)    
Infections and infestations     
Pneumonia * 1  0/354 (0.00%)  0 1/357 (0.28%)  1
Injury, poisoning and procedural complications     
Periprosthetic fracture * 1  1/354 (0.28%)  1 0/357 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Lower limb fracture * 1  1/354 (0.28%)  1 0/357 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma * 1  1/354 (0.28%)  1 0/357 (0.00%)  0
Nervous system disorders     
Cerebrovascular accident * 1  0/354 (0.00%)  0 1/357 (0.28%)  1
Transient ischaemic attack * 1  0/354 (0.00%)  0 1/357 (0.28%)  1
Respiratory, thoracic and mediastinal disorders     
Lung neoplasm malignant * 1  0/354 (0.00%)  0 1/357 (0.28%)  1
Vascular disorders     
Accelerated hypertension * 1  1/354 (0.28%)  1 0/357 (0.00%)  0
*
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%
Placebo Lifitegrast
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/354 (8.47%)      107/357 (29.97%)    
General disorders     
Instillation site irritation * 1  11/354 (3.11%)  12 65/357 (18.21%)  68
Instillation site reaction * 1  19/354 (5.37%)  21 45/357 (12.61%)  51
Nervous system disorders     
Dysgeusia * 1  1/354 (0.28%)  1 46/357 (12.89%)  46
*
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 multicenter 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 multicenter 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: 1 866-842-5335
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT02284516     History of Changes
Other Study ID Numbers: SHP606-304
First Submitted: October 30, 2014
First Posted: November 6, 2014
Results First Submitted: September 30, 2016
Results First Posted: March 15, 2017
Last Update Posted: January 9, 2019