Effect of Lifitegrast on Dry Eye Disease Signs and Symptoms
| Status: | Completed |
|---|---|
| Conditions: | Ocular, Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | December 12, 2016 |
| End Date: | March 15, 2018 |
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.
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.
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.
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
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