Trial Outcomes & Findings for Safety and Efficacy Study of SAR 1118 to Treat Dry Eye Conducted in a Controlled Adverse Environment (CAE) (OPUS-1) (NCT NCT01421498)
NCT ID: NCT01421498
Last Updated: 2021-06-11
Results Overview
Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. The staining was graded with the Ophthalmic Research Associates, Inc. (ORA) scale. 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/none; 1=occasional/trace; 2=countable/mild; 3=uncountable, but not confluent/moderate; 4=confluent/severe) with 0.5 point increments, and lower score indicates a better outcome. 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
588 participants
Baseline (Day 0) to Day 84
2021-06-11
Participant Flow
The study was conducted in a Controlled Adverse Environment (CAE).
Participant milestones
| Measure |
Lifitegrast 5.0%
|
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
293
|
295
|
|
Overall Study
COMPLETED
|
281
|
284
|
|
Overall Study
NOT COMPLETED
|
12
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study of SAR 1118 to Treat Dry Eye Conducted in a Controlled Adverse Environment (CAE) (OPUS-1)
Baseline characteristics by cohort
| Measure |
Lifitegrast 5.0%
n=293 Participants
|
Placebo
n=295 Participants
|
Total
n=588 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.2 years
STANDARD_DEVIATION 12.21 • n=5 Participants
|
61.1 years
STANDARD_DEVIATION 11.77 • n=7 Participants
|
60.6 years
STANDARD_DEVIATION 11.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
229 Participants
n=5 Participants
|
217 Participants
n=7 Participants
|
446 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Day 84Population: Intent-to-Treat (ITT) population with Last Observation Carried Forward (LOCF) included all randomized participants who received at least 1 dose of investigational product.
Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. The staining was graded with the Ophthalmic Research Associates, Inc. (ORA) scale. 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/none; 1=occasional/trace; 2=countable/mild; 3=uncountable, but not confluent/moderate; 4=confluent/severe) with 0.5 point increments, and lower score indicates a better outcome. 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 5.0%
n=293 Participants
|
Placebo
n=295 Participants
|
|---|---|---|
|
Ocular Sign: Change From Baseline in Inferior Corneal Fluorescein Staining to Day 84
|
-0.07 units on a scale
Standard Deviation 0.868
|
0.17 units on a scale
Standard Deviation 0.819
|
PRIMARY outcome
Timeframe: Baseline (Day 0) to Day 84Population: ITT population with LOCF.
The symptom functional scale is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the symptom functional scale questionnaire were graded on a scale of 0 (none of the time) to 4 (all of the time). The index consisted of 3 sub scales: symptoms (sensitivity to light, gritty sensation, pain, blurred vision, and poor vision \[Items 1-5\]), visual-related sub scale of the symptom functional scale (ability to read, drive at night, use a computer, watch television \[Items 6-9\]), and environmental triggers (windy conditions, low humidity, air conditioning \[Items 10-12\]). The symptom functional scale was scored on a scale of 0 to 100, with higher scores representing greater disability. Negative change from baseline indicates improvement.
Outcome measures
| Measure |
Lifitegrast 5.0%
n=293 Participants
|
Placebo
n=295 Participants
|
|---|---|---|
|
Ocular Symptom: Change From Baseline in Visual-Related Subscale of the Symptom Functional Scale Score to Day 84
|
-0.11 units on a scale
Standard Deviation 0.829
|
-0.12 units on a scale
Standard Deviation 0.762
|
Adverse Events
Lifitegrast 5.0%
Placebo
Serious adverse events
| Measure |
Lifitegrast 5.0%
n=293 participants at risk
|
Placebo
n=295 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.34%
1/293 • Number of events 1
|
0.00%
0/295
|
|
General disorders
Non-Cardiac chest pain
|
0.34%
1/293 • Number of events 1
|
0.00%
0/295
|
|
Infections and infestations
Infectious peritonitis
|
0.34%
1/293 • Number of events 1
|
0.00%
0/295
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.34%
1/293 • Number of events 1
|
0.00%
0/295
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/293
|
0.34%
1/295 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/293
|
0.34%
1/295 • Number of events 1
|
|
Nervous system disorders
Presyncope
|
0.34%
1/293 • Number of events 1
|
0.00%
0/295
|
Other adverse events
| Measure |
Lifitegrast 5.0%
n=293 participants at risk
|
Placebo
n=295 participants at risk
|
|---|---|---|
|
Eye disorders
Visual acuity reduced
|
4.8%
14/293 • Number of events 17
|
5.1%
15/295 • Number of events 18
|
|
General disorders
Instillation site irritation
|
23.5%
69/293 • Number of events 70
|
4.1%
12/295 • Number of events 12
|
|
General disorders
Instillation site pain
|
21.5%
63/293 • Number of events 63
|
3.7%
11/295 • Number of events 11
|
|
General disorders
Instillation site pruritus
|
6.5%
19/293 • Number of events 19
|
2.0%
6/295 • Number of events 6
|
|
General disorders
Instillation site reaction
|
17.1%
50/293 • Number of events 52
|
0.68%
2/295 • Number of events 2
|
|
Nervous system disorders
Dysgeusia
|
13.3%
39/293 • Number of events 40
|
0.00%
0/295
|
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