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Evaluate the efficacy and safety of Lifitegrast in subjects with dry eye disease and a recent history of artificial tear use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifitegrast | Experimental | Lifitegrast Ophthalmic Solution 5%, BID for 84 days |
|
| Placebo | Placebo Comparator | Placebo to match active treatment, BID for 84 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifitegrast | Drug | Lifitegrast Ophthalmic Solution 5%, BID for 84 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to Day 14 and Day 42 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham, UAB School of Optometry | Birmingham | Alabama | 35294 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34617974 | Derived | Holland EJ, Jackson MA, Donnenfeld E, Piccolo R, Cohen A, Barabino S, Rolando M, Figueiredo FC. Efficacy of Lifitegrast Ophthalmic Solution, 5.0%, in Patients With Moderate to Severe Dry Eye Disease: A Post Hoc Analysis of 2 Randomized Clinical Trials. JAMA Ophthalmol. 2021 Nov 1;139(11):1200-1208. doi: 10.1001/jamaophthalmol.2021.3943. | |
| 28079022 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo ophthalmic solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days. |
| FG001 | Lifitegrast | Lifitegrast 5% Ophthalmic Solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo |
| Drug |
Placebo to match active treatment, BID for 84 days |
|
| Arizona Eye Center |
| Chandler |
| Arizona |
| 85225 |
| United States |
| Sall Research Medical Center | Artesia | California | 90701 | United States |
| United Medical Research Institute | Inglewood | California | 90301 | United States |
| North Valley Eye Medical Group, Inc | Mission Hills | California | 91345 | United States |
| Montebello Medical Eye Center, Inc. | Montebello | California | 90640 | United States |
| Eye Research Foundation | Newport Beach | California | 92663 | United States |
| Arch Health Partners | Poway | California | 92064 | United States |
| Martel Eye Medical Group | Rancho Cordova | California | 95670 | United States |
| Shasta Eye Medical Group, Inc. | Redding | California | 96001 | United States |
| West Coast Eye Care Associates | San Diego | California | 92115 | United States |
| Chicago Cornea Consultants, Ltd. | Hoffman Estates | Illinois | 60169 | United States |
| Jackson Eye, SC | Lake Villa | Illinois | 60046 | United States |
| Price Vision Group | Indianapolis | Indiana | 46260 | United States |
| John-Kenyon American Eye Institute | New Albany | Indiana | 47150 | United States |
| Koffler Vision Group | Lexington | Kentucky | 40509 | United States |
| The Eye Care Institute | Louisville | Kentucky | 40206 | United States |
| Holpro Vision, Ltd. | Union | Kentucky | 41091 | United States |
| Clinical Eye Research of Boston | Winchester | Massachusetts | 01890 | United States |
| Lifelong Vision Foundation | Chesterfield | Missouri | 63017 | United States |
| Tauber Eye Center | Kansas City | Missouri | 64111 | United States |
| Tekwani Vision Center | St Louis | Missouri | 63128 | United States |
| Ophthalmology Consultants, Ltd. | St Louis | Missouri | 63131 | United States |
| Comprehensive Eye Care, Ltd. | Washington | Missouri | 63090 | United States |
| Wellish Vision Institute | Las Vegas | Nevada | 89119 | United States |
| Abrams Eye Institute | Las Vegas | Nevada | 89148 | United States |
| Clinical Vision Research Center at SUNY | New York | New York | 10036 | United States |
| Ophthalmic Consultants Of Long Island | Rockville Centre | New York | 11570 | United States |
| South Shore Eye Care, LLP | Wantagh | New York | 11793 | United States |
| Abrams Eye Center | Cleveland | Ohio | 44115 | United States |
| Scott & Christie and Associates, PC | Cranberry Township | Pennsylvania | 16066 | United States |
| Matossian Eye Associates | Doylestown | Pennsylvania | 18902 | United States |
| Toyos Clinic | Nashville | Tennessee | 37203 | United States |
| The Cataract & Glaucoma Center | El Paso | Texas | 79902 | United States |
| Advanced Laser Vision and Surgical Institute | Houston | Texas | 77034 | United States |
| Whitsett Vision Group | Houston | Texas | 77056 | United States |
| University of Houston College of Optometry | Houston | Texas | 77204 | United States |
| The Eye Clinic of Texas (Houston Eye Associates) | League City | Texas | 77573 | United States |
| Eye Clinics of South Texas, P.A. | San Antonio | Texas | 78209 | United States |
| R and R Eye Research, LLC. | San Antonio | Texas | 78229 | United States |
| See Clearly Vision | McLean | Virginia | 22012 | United States |
| Holland EJ, Luchs J, Karpecki PM, Nichols KK, Jackson MA, Sall K, Tauber J, Roy M, Raychaudhuri A, Shojaei A. Lifitegrast for the Treatment of Dry Eye Disease: Results of a Phase III, Randomized, Double-Masked, Placebo-Controlled Trial (OPUS-3). Ophthalmology. 2017 Jan;124(1):53-60. doi: 10.1016/j.ophtha.2016.09.025. Epub 2016 Oct 27. |
| Safety Population |
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| COMPLETED |
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| NOT COMPLETED |
|
Randomized population included all participants screened for whom a randomization number was assigned.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo ophthalmic solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days. |
| BG001 | Lifitegrast | Lifitegrast 5% Ophthalmic Solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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| 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 | 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Day 84 |
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| 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). | ITT population with LOCF. Here, n = number of participants analyzed for the specific categories of each arm, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Day 14 and Day 42 |
|
|
From start of the study drug administration upto Day 91 or Early termination (ET)
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo ophthalmic solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days. | 4 | 354 | 30 | 354 | ||
| EG001 | Lifitegrast | Lifitegrast 5% Ophthalmic Solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days. | 4 | 357 | 107 | 357 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Periprosthetic fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Lower limb fracture | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
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| Lung neoplasm malignant | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Accelerated hypertension | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Instillation site irritation | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Instillation site reaction | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
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If a multicenter 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 multicenter 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 |
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| ID | Term |
|---|---|
| C575157 | lifitegrast |
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| Male |
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