Trial Outcomes & Findings for A Phase 3 Study to Evaluate the Efficacy of Lifitegrast in Subjects With Dry Eye (NCT NCT01743729)
NCT ID: NCT01743729
Last Updated: 2021-06-23
Results Overview
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.
COMPLETED
PHASE3
720 participants
Baseline to Day 84
2021-06-23
Participant Flow
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.
Participant milestones
| Measure |
Lifitegrast
|
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
358
|
360
|
|
Overall Study
COMPLETED
|
321
|
348
|
|
Overall Study
NOT COMPLETED
|
37
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 3 Study to Evaluate the Efficacy of Lifitegrast in Subjects With Dry Eye
Baseline characteristics by cohort
| Measure |
Lifitegrast
n=358 Participants
|
Placebo
n=360 Participants
|
Total
n=718 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.7 years
STANDARD_DEVIATION 13.93 • n=5 Participants
|
58.9 years
STANDARD_DEVIATION 14.26 • n=7 Participants
|
58.8 years
STANDARD_DEVIATION 14.09 • n=5 Participants
|
|
Sex: Female, Male
Female
|
285 Participants
n=5 Participants
|
265 Participants
n=7 Participants
|
550 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 84Population: Intent-to-treat (ITT) set included all randomized participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
Lifitegrast
n=358 Participants
|
Placebo
n=360 Participants
|
|---|---|---|
|
Change From Baseline in Inferior Corneal Fluorescein Staining Score to Day 84
Baseline
|
2.39 units on a scale
Standard Deviation 0.763
|
2.40 units on a scale
Standard Deviation 0.722
|
|
Change From Baseline in Inferior Corneal Fluorescein Staining Score to Day 84
Change from Baseline to Day 84
|
-0.73 units on a scale
Standard Deviation 0.926
|
-0.71 units on a scale
Standard Deviation 0.943
|
PRIMARY outcome
Timeframe: Baseline to Day 84Population: ITT population with last observation carried forward (LOCF).
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.
Outcome measures
| Measure |
Lifitegrast
n=358 Participants
|
Placebo
n=360 Participants
|
|---|---|---|
|
Change From Baseline in Eye Dryness Score (Visual Analogue Scale) to Day 84
Baseline
|
69.68 units on a scale
Standard Deviation 16.954
|
69.22 units on a scale
Standard Deviation 16.761
|
|
Change From Baseline in Eye Dryness Score (Visual Analogue Scale) to Day 84
Change from Baseline to Day 84
|
-35.30 units on a scale
Standard Deviation 28.400
|
-22.75 units on a scale
Standard Deviation 28.600
|
Adverse Events
Lifitegrast
Placebo
Serious adverse events
| Measure |
Lifitegrast
n=359 participants at risk
|
Placebo
n=359 participants at risk
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.28%
1/359 • Number of events 1
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.
|
0.00%
0/359
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.
|
|
Endocrine disorders
Thyrotoxic crisis
|
0.28%
1/359 • Number of events 1
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.
|
0.00%
0/359
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.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/359
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.
|
0.28%
1/359 • Number of events 1
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.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/359
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.
|
0.28%
1/359 • Number of events 1
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/359
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.
|
0.28%
1/359 • Number of events 1
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.28%
1/359 • Number of events 1
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.
|
0.00%
0/359
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.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/359
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.
|
0.28%
1/359 • Number of events 1
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.
|
Other adverse events
| Measure |
Lifitegrast
n=359 participants at risk
|
Placebo
n=359 participants at risk
|
|---|---|---|
|
Eye disorders
Visual acuity reduced
|
5.0%
18/359 • Number of events 23
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.
|
6.4%
23/359 • Number of events 28
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.
|
|
General disorders
Instillation site irritation
|
7.8%
28/359 • Number of events 29
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.
|
1.4%
5/359 • Number of events 5
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.
|
|
General disorders
Instillation site reaction
|
7.0%
25/359 • Number of events 29
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.
|
1.1%
4/359 • Number of events 4
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.
|
|
Nervous system disorders
Dysgeusia
|
16.2%
58/359 • Number of events 58
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.
|
0.28%
1/359 • Number of events 1
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.
|
Additional Information
Study Director
Shire (Note: Lifitegrast was divested to Novartis in 2019)
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER