Dry Eye Disease
Conditions
Brief summary
The purpose of the study is to evaluate the safety of lifitegrast ophthalmic solution compared to placebo in the treatment of dry eye as assessed by ocular and non-ocular adverse events when administered BID for approximately 1 year.
Interventions
DRUGLifitegrast
Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: \ 1 year
DRUGPlacebo
Dosage Form: Ophthalmic Solution Dosage: placebo Frequency: BID Duration: \ 1 year
Sponsors
Shire
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Willing and able to read, sign and date the informed consent and HIPAA documents * Willing and able to comply with all study procedures * Be at least 18 years of age * Patient-reported history of dry eye in both eyes * A negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period
Exclusion criteria
* Any ocular condition that, in the opinion of the Investigator, could affect study parameters including, but not limited to, active ocular infection, ocular inflammation, glaucoma, and/or diabetic retinopathy * Unwilling to avoid wearing contact lenses for 24h prior to Visit 1 and for some duration during the study * Any blood donation or significant loss of blood within 56 days of Visit 1 * Any history of immunodeficiency disorder, positive HIV, hepatitis B, C, or evidence of acute active hepatitis A (anti-HAV IgM), or organ or bone marrow transplant. * Use of any prohibited medications during the appropriate pre-study washout period and at any time during the study unless otherwise specified * Any significant illness that could interfere with study parameters * History of laser-assisted in situ keratomileusis (LASIK) or similar type of corneal refractive surgery within 12 months prior to Visit 1, and/or any other ocular surgical procedure within 12 months prior to Visit 1; or any scheduled ocular surgical procedure during the study period. * Known history of alcohol and/or drug abuse * Subjects with Dry eye secondary to scarring or destruction of conjunctival goblet cells (as with Vitamin A deficiency)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Ocular and Nonocular Treatment Emergent Adverse Events (TEAEs) for 1 Year | Day 0 to Day 360 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo | 111 |
| Lifitegrast | 221 |
| Total | 332 |
Baseline characteristics
| Characteristic | Placebo | Lifitegrast | Total |
|---|---|---|---|
| Age, Continuous | 61.0 years STANDARD_DEVIATION 13.18 | 58.8 years STANDARD_DEVIATION 12.39 | 59.5 years STANDARD_DEVIATION 12.68 |
| Sex: Female, Male Female | 85 Participants | 165 Participants | 250 Participants |
| Sex: Female, Male Male | 26 Participants | 56 Participants | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 22 / 111 | 92 / 220 |
| serious Total, serious adverse events | 6 / 111 | 9 / 220 |
Outcome results
Primary
Number of Participants With Ocular and Nonocular Treatment Emergent Adverse Events (TEAEs) for 1 Year
Time frame: Day 0 to Day 360
Population: Safety population included all randomized participants who received at least 1 dose of investigational product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Ocular and Nonocular Treatment Emergent Adverse Events (TEAEs) for 1 Year | Ocular TEAE | 38 participants |
| Placebo | Number of Participants With Ocular and Nonocular Treatment Emergent Adverse Events (TEAEs) for 1 Year | Non-ocular TEAE | 40 participants |
| Lifitegrast | Number of Participants With Ocular and Nonocular Treatment Emergent Adverse Events (TEAEs) for 1 Year | Ocular TEAE | 118 participants |
| Lifitegrast | Number of Participants With Ocular and Nonocular Treatment Emergent Adverse Events (TEAEs) for 1 Year | Non-ocular TEAE | 104 participants |