Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy of three different concentrations (0.1%, 1.0%, 5.0%) of SAR 1118 Ophthalmic Solution compared to placebo in the treatment of dry eye.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo Ophthalmic Solution |
|
| 0.1% Lifitegrast | Experimental | Lifitegrast |
|
| 1.0% Lifitegrast | Experimental | Lifitegrast |
|
| 5.0% Lifitegrast | Experimental | Lifitegrast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifitegrast | Drug | Ophthalmic Solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inferior Corneal Fluorescein Staining Score in Pre-Controlled Adverse Environment at 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; 1=occasional; 2=countable; 3=uncountable, but not confluent; 4=confluent) 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. | Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Inferior Corneal Staining Score Change From Baseline (CFB) 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; 1=occasional; 2=countable; 3=uncountable, but not confluent; 4=confluent) 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Eye Care Group | Waterbury | Connecticut | 06708 | United States | ||
| Central Maine Eye Care |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22330307 | Derived | Semba CP, Torkildsen GL, Lonsdale JD, McLaurin EB, Geffin JA, Mundorf TK, Kennedy KS, Ousler GW. A phase 2 randomized, double-masked, placebo-controlled study of a novel integrin antagonist (SAR 1118) for the treatment of dry eye. Am J Ophthalmol. 2012 Jun;153(6):1050-60.e1. doi: 10.1016/j.ajo.2011.11.003. Epub 2012 Feb 11. |
Not provided
Not provided
The study was conducted in a Controlled Adverse Environment (CAE).
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lifitegrast 0.1% | |
| FG001 | Lifitegrast 1.0% | |
| FG002 | Lifitegrast 5.0% |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Ophthalmic Solution |
|
| Baseline (Day 0) and Day 84 |
| Lewiston |
| Maine |
| 04243 |
| United States |
| Ora, Inc. (two locations) | Andover | Massachusetts | 01840 | United States |
| Mundorf Eye Center | Charlotte | North Carolina | 28204 | United States |
| Total Eye Care, P.A. | Memphis | Tennessee | 38119 | United States |
| FG003 | Placebo |
| COMPLETED |
|
| NOT COMPLETED |
|
Intent-to-treat (ITT) set included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lifitegrast 0.1% | |
| BG001 | Lifitegrast 1.0% | |
| BG002 | Lifitegrast 5.0% | |
| BG003 | Placebo | |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Inferior Corneal Fluorescein Staining Score in Pre-Controlled Adverse Environment at 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; 1=occasional; 2=countable; 3=uncountable, but not confluent; 4=confluent) 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. | Intent-to-treat (ITT) population with LOCF defined as all randomized subjects. For the efficacy analysis, the Last Observation Carried Forward (LOCF) method will be used to impute missing values. | Posted | Mean | Standard Deviation | units on a scale | Day 84 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Inferior Corneal Staining Score Change From Baseline (CFB) 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; 1=occasional; 2=countable; 3=uncountable, but not confluent; 4=confluent) 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. | ITT set with LOCF was used for analysis of this outcome. Here, "n" signifies the number of participants evaluable for the respective time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0) and Day 84 |
|
From the first dose of study drug until the end of follow-up visit, up to Day 86
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lifitegrast 0.1% | 2 | 57 | 20 | 57 | |||
| EG001 | Lifitegrast 1.0% | 1 | 57 | 13 | 57 | |||
| EG002 | Lifitegrast 5.0% | 0 | 58 | 40 | 58 | |||
| EG003 | Placebo | 1 | 58 | 11 | 58 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival haemorrhage | Eye disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Instillation site irritation | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Instillation site pain | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Instillation site reaction | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire (Note: Lifitegrast was divested to Novartis in 2019) | +1 866 842 5335 | ClinicalTransparency@shire.com |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C575157 | lifitegrast |
Not provided
Not provided
Not provided
| Male |
|
| 0.3585 |
| Treatment Effect |
| 0.20 |
| 2-Sided |
| 95 |
| -0.13 |
| 0.53 |
Analysis of covariance model with treatment, baseline, and site. |
| Superiority or Other (legacy) |
| Dunnett's test | 0.1375 | Treatment Effect | 0.27 | 2-Sided | 95 | -0.06 | 0.60 | Analysis of covariance model with treatment, baseline, and site. | Superiority or Other (legacy) |
| Units | Counts |
|---|---|
| Participants |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|