Dry Eye
Conditions
Keywords
Dry eye, Tear osmolarity, Lifitegrast
Brief summary
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.
Detailed description
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.
Interventions
DRUGLifitegrast
All subjects meet dry eye inclusion and will be treated with Lifitegrast gtts BID
Sponsors
Lifelong Vision Foundation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Tear Osmolarity \> 320 mOsm/L * VAS eye dryness \> 40 * No other ocular pathology * No contact lens wear * Not currently on T cell modulator * No change in therapy in last 2 months * Willingness to adhere to therapy and study visits * Patients qualified for prescription of lifitegrast drops
Exclusion criteria
* Contact lens use * Eye surgery in Past 6 months * Use of tear supplements in past 2 hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary: Tear osmolarity | Baseline to the study completion, up to 3 months. | Number of participants with an improvement in Tear Osmolarity measured using the Tear Osmolarity score treated with Lifitegrast. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS | VAS dry eye questionnaire, tear break up time and meibomian gland grading will be serially measured over 3 months during treatment with Lifitegrast gtts | 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. |
| Corneal Staining Grade | Baseline to the study completion, up to 3 months. | Percentage of cornea with cell loss/fluorescein dye uptake. The higher the percentage the higher the grade. |
| TBUT | Baseline to the study completion, up to 3 months. | Tear Film Break-Up Time; measurement of seconds it take for the tear film to start evaporating from the cornea. |
| MGD grade | Baseline to the study completion, up to 3 months. | Visual grading of Meibomian gland clogging. |
Countries
United States
Outcome results
None listed