Trial Outcomes & Findings for Safety Study of Lifitegrast to Treat Dry Eye (NCT NCT01636206)
NCT ID: NCT01636206
Last Updated: 2021-06-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
332 participants
Primary outcome timeframe
Day 0 to Day 360
Results posted on
2021-06-11
Participant Flow
Participant milestones
| Measure |
Placebo
|
Lifitegrast
|
|---|---|---|
|
Overall Study
STARTED
|
111
|
221
|
|
Overall Study
COMPLETED
|
92
|
170
|
|
Overall Study
NOT COMPLETED
|
19
|
51
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety Study of Lifitegrast to Treat Dry Eye
Baseline characteristics by cohort
| Measure |
Placebo
n=111 Participants
|
Lifitegrast
n=221 Participants
|
Total
n=332 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.0 years
STANDARD_DEVIATION 13.18 • n=5 Participants
|
58.8 years
STANDARD_DEVIATION 12.39 • n=7 Participants
|
59.5 years
STANDARD_DEVIATION 12.68 • n=5 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=5 Participants
|
165 Participants
n=7 Participants
|
250 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 to Day 360Population: Safety population included all randomized participants who received at least 1 dose of investigational product.
Outcome measures
| Measure |
Placebo
n=111 Participants
|
Lifitegrast
n=220 Participants
|
|---|---|---|
|
Number of Participants With Ocular and Nonocular Treatment Emergent Adverse Events (TEAEs) for 1 Year
Ocular TEAE
|
38 participants
|
118 participants
|
|
Number of Participants With Ocular and Nonocular Treatment Emergent Adverse Events (TEAEs) for 1 Year
Non-ocular TEAE
|
40 participants
|
104 participants
|
Adverse Events
Placebo
Serious events: 6 serious events
Other events: 22 other events
Deaths: 0 deaths
Lifitegrast
Serious events: 9 serious events
Other events: 92 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=111 participants at risk
|
Lifitegrast
n=220 participants at risk
|
|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.90%
1/111 • Number of events 1
|
0.00%
0/220
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/111
|
0.45%
1/220 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/111
|
0.45%
1/220 • Number of events 1
|
|
General disorders
Chest pain
|
0.90%
1/111 • Number of events 1
|
0.00%
0/220
|
|
Infections and infestations
Pneumonia
|
0.00%
0/111
|
0.45%
1/220 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/111
|
0.45%
1/220 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/111
|
0.45%
1/220 • Number of events 1
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.90%
1/111 • Number of events 1
|
0.00%
0/220
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/111
|
0.45%
1/220 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.90%
1/111 • Number of events 1
|
0.00%
0/220
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/111
|
0.45%
1/220 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/111
|
0.45%
1/220 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colonic polyp
|
0.00%
0/111
|
0.45%
1/220 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.00%
0/111
|
0.45%
1/220 • Number of events 1
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/111
|
0.45%
1/220 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.8%
2/111 • Number of events 2
|
0.00%
0/220
|
|
Vascular disorders
Transient ischaemic attack
|
0.00%
0/111
|
0.45%
1/220 • Number of events 1
|
Other adverse events
| Measure |
Placebo
n=111 participants at risk
|
Lifitegrast
n=220 participants at risk
|
|---|---|---|
|
Eye disorders
Dry eye
|
5.4%
6/111 • Number of events 6
|
1.8%
4/220 • Number of events 4
|
|
Eye disorders
Visual acuity reduced
|
6.3%
7/111 • Number of events 8
|
11.4%
25/220 • Number of events 28
|
|
General disorders
Instillation site irritation
|
4.5%
5/111 • Number of events 5
|
15.0%
33/220 • Number of events 33
|
|
General disorders
Instillation site reaction
|
1.8%
2/111 • Number of events 2
|
13.2%
29/220 • Number of events 30
|
|
Nervous system disorders
Dysgeusia
|
1.8%
2/111 • Number of events 2
|
16.4%
36/220 • Number of events 36
|
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 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