Trial Outcomes & Findings for A Study to Evaluate Efficacy and Safety of Lifitegrast in Subjects With Dry Eye (OPUS-3) (NCT NCT02284516)
NCT ID: NCT02284516
Last Updated: 2021-06-11
Results Overview
Eye dryness score was scored on a Visual Analogue Scale (VAS) ranges from 0-100 (0=no discomfort; 100=maximal discomfort).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
711 participants
Primary outcome timeframe
Baseline to Day 84
Results posted on
2021-06-11
Participant Flow
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.
Participant milestones
| Measure |
Placebo
Placebo ophthalmic solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
|
Lifitegrast
Lifitegrast 5% Ophthalmic Solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
|
|---|---|---|
|
Overall Study
NOT COMPLETED
|
38
|
36
|
|
Overall Study
STARTED
|
356
|
355
|
|
Overall Study
Safety Population
|
354
|
357
|
|
Overall Study
COMPLETED
|
318
|
319
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate Efficacy and Safety of Lifitegrast in Subjects With Dry Eye (OPUS-3)
Baseline characteristics by cohort
| Measure |
Placebo
n=356 Participants
Placebo ophthalmic solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
|
Lifitegrast
n=355 Participants
Lifitegrast 5% Ophthalmic Solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
|
Total
n=711 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.6 years
STANDARD_DEVIATION 14.84 • n=5 Participants
|
58.8 years
STANDARD_DEVIATION 14.10 • n=7 Participants
|
58.7 years
STANDARD_DEVIATION 14.47 • n=5 Participants
|
|
Sex: Female, Male
Female
|
269 Participants
n=5 Participants
|
268 Participants
n=7 Participants
|
537 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 84Population: 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.
Eye dryness score was scored on a Visual Analogue Scale (VAS) ranges from 0-100 (0=no discomfort; 100=maximal discomfort).
Outcome measures
| Measure |
Placebo
n=356 Participants
Placebo ophthalmic solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
|
Lifitegrast
n=355 Participants
Lifitegrast 5% Ophthalmic Solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
|
|---|---|---|
|
Change From Baseline in Patient-Reported Eye Dryness Score to Day 84
Baseline (n=356, 355)
|
69.0 units on a scale
Standard Deviation 17.08
|
68.3 units on a scale
Standard Deviation 16.88
|
|
Change From Baseline in Patient-Reported Eye Dryness Score to Day 84
Change from Baseline to Day 84 (n=353, 353)
|
-30.7 units on a scale
Standard Deviation 28.01
|
-37.9 units on a scale
Standard Deviation 28.85
|
SECONDARY outcome
Timeframe: Baseline to Day 14 and Day 42Population: ITT population with LOCF. Here, n = number of participants analyzed for the specific categories of each arm, respectively.
Eye dryness score was scored on a Visual Analogue Scale (VAS) ranges from 0-100 (0=no discomfort; 100=maximal discomfort).
Outcome measures
| Measure |
Placebo
n=356 Participants
Placebo ophthalmic solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
|
Lifitegrast
n=355 Participants
Lifitegrast 5% Ophthalmic Solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
|
|---|---|---|
|
Change From Baseline in Patient-Reported Eye Dryness Score to Day 14 and Day 42
Baseline (n=356, 355)
|
69.0 units on a scale
Standard Deviation 17.08
|
68.3 units on a scale
Standard Deviation 16.88
|
|
Change From Baseline in Patient-Reported Eye Dryness Score to Day 14 and Day 42
Change from Baseline to Day 14 (n=353, 352)
|
-15.0 units on a scale
Standard Deviation 22.40
|
-22.9 units on a scale
Standard Deviation 25.44
|
|
Change From Baseline in Patient-Reported Eye Dryness Score to Day 14 and Day 42
Change from Baseline to Day 42 (n=353, 353)
|
-23.9 units on a scale
Standard Deviation 25.99
|
-33.2 units on a scale
Standard Deviation 27.42
|
Adverse Events
Placebo
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
Lifitegrast
Serious events: 4 serious events
Other events: 107 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=354 participants at risk
Placebo ophthalmic solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
|
Lifitegrast
n=357 participants at risk
Lifitegrast 5% Ophthalmic Solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/354 • From start of the study drug administration upto Day 91 or Early termination (ET)
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.
|
0.28%
1/357 • Number of events 1 • From start of the study drug administration upto Day 91 or Early termination (ET)
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.
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.28%
1/354 • Number of events 1 • From start of the study drug administration upto Day 91 or Early termination (ET)
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.
|
0.00%
0/357 • From start of the study drug administration upto Day 91 or Early termination (ET)
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.
|
|
Musculoskeletal and connective tissue disorders
Lower limb fracture
|
0.28%
1/354 • Number of events 1 • From start of the study drug administration upto Day 91 or Early termination (ET)
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.
|
0.00%
0/357 • From start of the study drug administration upto Day 91 or Early termination (ET)
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.28%
1/354 • Number of events 1 • From start of the study drug administration upto Day 91 or Early termination (ET)
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.
|
0.00%
0/357 • From start of the study drug administration upto Day 91 or Early termination (ET)
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.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/354 • From start of the study drug administration upto Day 91 or Early termination (ET)
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.
|
0.28%
1/357 • Number of events 1 • From start of the study drug administration upto Day 91 or Early termination (ET)
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.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/354 • From start of the study drug administration upto Day 91 or Early termination (ET)
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.
|
0.28%
1/357 • Number of events 1 • From start of the study drug administration upto Day 91 or Early termination (ET)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Lung neoplasm malignant
|
0.00%
0/354 • From start of the study drug administration upto Day 91 or Early termination (ET)
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.
|
0.28%
1/357 • Number of events 1 • From start of the study drug administration upto Day 91 or Early termination (ET)
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.
|
|
Vascular disorders
Accelerated hypertension
|
0.28%
1/354 • Number of events 1 • From start of the study drug administration upto Day 91 or Early termination (ET)
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.
|
0.00%
0/357 • From start of the study drug administration upto Day 91 or Early termination (ET)
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.
|
Other adverse events
| Measure |
Placebo
n=354 participants at risk
Placebo ophthalmic solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
|
Lifitegrast
n=357 participants at risk
Lifitegrast 5% Ophthalmic Solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
|
|---|---|---|
|
General disorders
Instillation site irritation
|
3.1%
11/354 • Number of events 12 • From start of the study drug administration upto Day 91 or Early termination (ET)
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.
|
18.2%
65/357 • Number of events 68 • From start of the study drug administration upto Day 91 or Early termination (ET)
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.
|
|
General disorders
Instillation site reaction
|
5.4%
19/354 • Number of events 21 • From start of the study drug administration upto Day 91 or Early termination (ET)
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.
|
12.6%
45/357 • Number of events 51 • From start of the study drug administration upto Day 91 or Early termination (ET)
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.
|
|
Nervous system disorders
Dysgeusia
|
0.28%
1/354 • Number of events 1 • From start of the study drug administration upto Day 91 or Early termination (ET)
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.
|
12.9%
46/357 • Number of events 46 • From start of the study drug administration upto Day 91 or Early termination (ET)
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.
|
Additional Information
Study Director
Shire (Note: Lifitegrast was divested to Novartis in 2019)
Phone: +1 866 842 5335
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER