Dry Eye Disease
Conditions
Brief summary
Evaluate the efficacy and safety of Lifitegrast in subjects with dry eye disease and a recent history of artificial tear use.
Interventions
DRUGLifitegrast
Lifitegrast Ophthalmic Solution 5%, BID for 84 days
DRUGPlacebo
Placebo to match active treatment, BID for 84 days
Sponsors
Shire
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient-reported history of Dry Eye Disease in both eyes. * Use of over the counter artificial tears within the past 30 days. * A negative urine pregnancy test for females and willingness to use adequate birth control throughout the study. * Able and willing to comply with all study procedures.
Exclusion criteria
* Presence of an ocular condition that could affect the study parameters such as active ocular infections, ocular inflammation, glaucoma, or diabetic retinopathy;. * Unwilling to stop wearing contact lenses during the study. * LASIK or other ocular surgical procedures within 12 months prior to or during the study. * Use of prohibited medications * Significant medical conditions that could affect the study parameters.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Patient-Reported Eye Dryness Score to Day 84 | Baseline to Day 84 | Eye dryness score was scored on a Visual Analogue Scale (VAS) ranges from 0-100 (0=no discomfort; 100=maximal discomfort). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Patient-Reported Eye Dryness Score to Day 14 and Day 42 | Baseline to Day 14 and Day 42 | Eye dryness score was scored on a Visual Analogue Scale (VAS) ranges from 0-100 (0=no discomfort; 100=maximal discomfort). |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo ophthalmic solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days. | 356 |
| Lifitegrast Lifitegrast 5% Ophthalmic Solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days. | 355 |
| Total | 711 |
Baseline characteristics
| Characteristic | Placebo | Lifitegrast | Total |
|---|---|---|---|
| Age, Continuous | 58.6 years STANDARD_DEVIATION 14.84 | 58.8 years STANDARD_DEVIATION 14.1 | 58.7 years STANDARD_DEVIATION 14.47 |
| Sex: Female, Male Female | 269 Participants | 268 Participants | 537 Participants |
| Sex: Female, Male Male | 87 Participants | 87 Participants | 174 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 30 / 354 | 107 / 357 |
| serious Total, serious adverse events | 4 / 354 | 4 / 357 |
Outcome results
Primary
Change From Baseline in Patient-Reported Eye Dryness Score to Day 84
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Lifitegrast | Change From Baseline in Patient-Reported Eye Dryness Score to Day 84 | Baseline (n=356, 355) | 68.3 units on a scale | Standard Deviation 16.88 |
| Lifitegrast | Change From Baseline in Patient-Reported Eye Dryness Score to Day 84 | Change from Baseline to Day 84 (n=353, 353) | -37.9 units on a scale | Standard Deviation 28.85 |
p-value: =0.000795% CI: [3.04, 11.28]ANOVA
Secondary
Change From Baseline in Patient-Reported Eye Dryness Score to Day 14 and Day 42
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
Population: ITT population with LOCF. Here, n = number of participants analyzed for the specific categories of each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 22.4 |
| Placebo | 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 |
| Lifitegrast | Change From Baseline in Patient-Reported Eye Dryness Score to Day 14 and Day 42 | Baseline (n=356, 355) | 68.3 units on a scale | Standard Deviation 16.88 |
| Lifitegrast | Change From Baseline in Patient-Reported Eye Dryness Score to Day 14 and Day 42 | Change from Baseline to Day 14 (n=353, 352) | -22.9 units on a scale | Standard Deviation 25.44 |
| Lifitegrast | Change From Baseline in Patient-Reported Eye Dryness Score to Day 14 and Day 42 | Change from Baseline to Day 42 (n=353, 353) | -33.2 units on a scale | Standard Deviation 27.42 |
Comparison: Baseline and Day 14p-value: <0.000195% CI: [4.33, 11.37]ANOVA
Comparison: Baseline and Day 42p-value: <0.000195% CI: [5.44, 13.2]ANOVA