Effect of Lifitegrast on Dry Eye Disease Signs and Symptoms

Dry Eye Clinical Trial

— Lifitegrast  

Official title:

Effect of Lifitegrast on Dry Eye Disease Signs and Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03451396
• Other study ID #: 5720
• Status: Completed
• Phase: Phase 4
• First received: December 1, 2016
• Last updated: March 16, 2018
• Start date: December 12, 2016
• Est. completion date: March 15, 2018

Study information

• Verified date: March 2018
• Source: Lifelong Vision Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 15, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca
• Signs and Symptoms

Intervention

Drug:
• Lifitegrast
All subjects meet dry eye inclusion and will be treated with Lifitegrast gtts BID

Locations

Country	Name	City	State
United States	Lifelong Vision Foundation	Chesterfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Lifelong Vision Foundation

Country where clinical trial is conducted

United States, 

References & Publications (3)

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- — View Citation

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 Jul 22:1-7. [Epub ahead o — View Citation

Sullivan BD, Crews LA, Sönmez 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 diseas — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	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
Secondary	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.
Secondary	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.
Secondary	MGD grade	Visual grading of Meibomian gland clogging.	Baseline to the study completion, up to 3 months.