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To determine whether a fall in tear osmolarity precedes improvement in symptoms and signs of dry eye in dry eye patients treated topically with 5% lifitegrast drops for 3 months.
A longitudinal, single-arm, prospective study will recruit up to 30 subjects with moderate to severe dry eye disease. Subjects will be >18 years of age, diagnosed with moderate to severe dry eye (tear osmolarity > 320 mOsm/L and Visual Analog Scale (VAS) score > 40), willing to adhere to twice daily dosing (BID) and follow up visit schedule, have no history of ocular pathology / degeneration / allergy, not on any T-cell modulatory therapy, not have instilled any artificial tears within 2 hours of study visit, and not participating in any concurrent clinical trials. All subjects will complete an informed consent form indicating their voluntary participation in the study.
Study measurements will be made at baseline (first clinic visit), 2-, 6-, and 12-weeks following Lifitegrast therapy and include tear osmolarity (TearLab osmolarity system), VAS questionnaire, slit lamp examination for fluorescein corneal staining, tear break up time (TBUT), and Meibomian gland dysfunction (MGD) grading . At the end of the 3-mo study visit, the subjects will be informed of study completion and exited from the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild Dry Eye Cohort | Active Comparator | Prospective 3 month study of subjects with Tear Osmolarity >308 and VAS eye dryness ≥ 40 using 5% Lifitegrast ophthalmic solution BID. |
|
| Moderate to Severe Dry Eye Cohort | Active Comparator | Prospective 3 month study of subjects with Tear Osmolarity >320 and VAS eye dryness ≥ 40 using 5% Lifitegrast ophthalmic solution BID. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifitegrast | Drug | All subjects meet dry eye inclusion and will be treated with Lifitegrast gtts BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary: Tear osmolarity | Number of participants with an improvement in Tear Osmolarity measured using the Tear Osmolarity score treated with Lifitegrast. | Baseline to the study completion, up to 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| VAS | Participants self scored mean average on a scale of 0: none to 10: severe of Eye Dryness, Burning/Stinging, Foreign Body Sensation, Pain, Photophobia, Itching, and Blurred Vision. | VAS dry eye questionnaire, tear break up time and meibomian gland grading will be serially measured over 3 months during treatment with Lifitegrast gtts |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jay S Pepose, MD, PhD | Pepose Vision Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lifelong Vision Foundation | Chesterfield | Missouri | 63017 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27388660 | Result | Holland EJ, Whitley WO, Sall K, Lane SS, Raychaudhuri A, Zhang SY, Shojaei A. Lifitegrast clinical efficacy for treatment of signs and symptoms of dry eye disease across three randomized controlled trials. Curr Med Res Opin. 2016 Oct;32(10):1759-1765. doi: 10.1080/03007995.2016.1210107. Epub 2016 Jul 22. | |
| 27055211 | Result |
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| 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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| Corneal Staining Grade |
Percentage of cornea with cell loss/fluorescein dye uptake. The higher the percentage the higher the grade. |
| Baseline to the study completion, up to 3 months. |
| TBUT | Tear Film Break-Up Time; measurement of seconds it take for the tear film to start evaporating from the cornea. | Baseline to the study completion, up to 3 months. |
| MGD grade | Visual grading of Meibomian gland clogging. | Baseline to the study completion, up to 3 months. |
| Donnenfeld ED, Karpecki PM, Majmudar PA, Nichols KK, Raychaudhuri A, Roy M, Semba CP. Safety of Lifitegrast Ophthalmic Solution 5.0% in Patients With Dry Eye Disease: A 1-Year, Multicenter, Randomized, Placebo-Controlled Study. Cornea. 2016 Jun;35(6):741-8. doi: 10.1097/ICO.0000000000000803. |
| 22475641 | Result | Sullivan BD, Crews LA, Sonmez B, de la Paz MF, Comert E, Charoenrook V, de Araujo AL, Pepose JS, Berg MS, Kosheleff VP, Lemp MA. Clinical utility of objective tests for dry eye disease: variability over time and implications for clinical trials and disease management. Cornea. 2012 Sep;31(9):1000-8. doi: 10.1097/ICO.0b013e318242fd60. |