A Phase 3 interventional study of Lifitegrast and Placebo in Keratoconjunctivitis Sicca and Dry Eye Disease, sponsored by Shire. Completed at 13 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-11.
Sponsored by Shire (part of Takeda) · Phase 3, Interventional, and Treatment
The purpose of the study is to evaluate the efficacy of SAR 1118 Ophthalmic Solution (5.0%) compared to placebo in the treatment of Dry Eye. The safety and tolerability of SAR 1118 Ophthalmic Solution (5.0%) compared to placebo in subjects with dry eye when administered BID for 12 weeks will also be evaluated.
85 studies on the registry are indexed under Keratoconjunctivitis Sicca; 1 is open to participants now.
This study's enrollment of 588 is above the median of 82 across 75 interventional studies indexed under Keratoconjunctivitis Sicca.
Browse Keratoconjunctivitis Sicca studies →Shire is the lead sponsor of 351 studies on the registry; 2 are open to participants now.
Of its 48 completed or terminated interventional studies of FDA-regulated products, 48 (100%) have results posted.
First submitted before Shire became part of Takeda.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lifitegrast
Drug: Lifitegrast
Placebo
Drug: Placebo
Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: 12 weeks
Also known as: SAR 1118
Dosage Form: Ophthalmic Solution Frequency: BID Duration: 12 weeks
Ocular Sign: Change From Baseline in Inferior Corneal Fluorescein Staining to Day 84
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.
Time frame: Baseline (Day 0) to Day 84
Ocular Symptom: Change From Baseline in Visual-Related Subscale of the Symptom Functional Scale Score to Day 84
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.
Time frame: Baseline (Day 0) to Day 84
| Milestone | Lifitegrast 5.0% | Placebo |
|---|---|---|
| Started | 293 | 295 |
| Completed | 281 | 284 |
| Not completed | 12 | 11 |
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.
| units on a scale | Lifitegrast 5.0% | Placebo |
|---|---|---|
| Ocular Sign: Change From Baseline in Inferior Corneal Fluorescein Staining to Day 84 | -0.07 ± 0.868 | 0.17 ± 0.819 |
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.
| units on a scale | Lifitegrast 5.0% | Placebo |
|---|---|---|
| Ocular Symptom: Change From Baseline in Visual-Related Subscale of the Symptom Functional Scale Score to Day 84 | -0.11 ± 0.829 | -0.12 ± 0.762 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lifitegrast 5.0% | — | 5/293 (1.7%) | 160/293 (54.6%) |
| Placebo | — | 2/295 (0.7%) | 40/295 (13.6%) |
| Event | Lifitegrast 5.0% | Placebo |
|---|---|---|
| Abdominal pain upperGastrointestinal disorders | 1/293 | 0/295 |
| Non-Cardiac chest painGeneral disorders | 1/293 | 0/295 |
| Infectious peritonitisInfections and infestations | 1/293 | 0/295 |
| Humerus fractureInjury, poisoning and procedural complications | 1/293 | 0/295 |
| PresyncopeNervous system disorders | 1/293 | 0/295 |
| Intervertebral disc protrusionMusculoskeletal and connective tissue disorders | 0/293 | 1/295 |
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/293 | 1/295 |
| Event | Lifitegrast 5.0% | Placebo |
|---|---|---|
| Instillation site irritationGeneral disorders | 69/293 | 12/295 |
| Instillation site painGeneral disorders | 63/293 | 11/295 |
| Instillation site reactionGeneral disorders | 50/293 | 2/295 |
| DysgeusiaNervous system disorders | 39/293 | 0/295 |
| Instillation site pruritusGeneral disorders | 19/293 | 6/295 |
| Visual acuity reducedEye disorders | 14/293 | 15/295 |
Safety population included all randomized participants who received at least 1 dose of investigational product.
| Age, Continuous(years) | Lifitegrast 5.0% | Placebo | Total |
|---|---|---|---|
| Mean | 60.2 ± 12.21 | 61.1 ± 11.77 | 60.6 ± 11.99 |
| Sex: Female, Male(Participants) | Lifitegrast 5.0% | Placebo | Total |
|---|---|---|---|
| Female | 229 | 217 | 446 |
| Male | 64 | 78 | 142 |
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Lifitegrast