A Single-Center Randomized Double-Masked Placebo-Controlled Parallel-Group, Study of the Effects and Safety of 5% Lifitegrast Ophthalmic Solution in Subjects With Dry Eye Disease in Ocular Graft-versus-Host Disease

Richard W Yee, MD1 site in 1 country30 target enrollmentOctober 22, 2022

ConditionsGraft-versus-host-disease Ocular Graft-versus-host Disease

InterventionsLifitegrast 5% Ophthalmic Solution Placebo

Overview

Phase: Early Phase 1
Intervention: Lifitegrast 5% Ophthalmic Solution
Conditions: Graft-versus-host-disease
Sponsor: Richard W Yee, MD
Enrollment: 30
Locations: 1
Primary Endpoint: Change from baseline in Symptoms questionnaire (SANDE) scores to Week 4
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to evaluate the clinical efficacy of 5% lifitegrast ophthalmic solution in subjects with dry eye disease secondary to ocular Graft-versus-Host Disease compared to placebo.

Registry

clinicaltrials.gov

Start Date

October 22, 2022

End Date

April 30, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Richard W Yee, MD

Responsible Party

Sponsor Investigator

Principal Investigator

Richard W Yee, MD

Sponsor-Investigator

Yee, Richard W., M.D.

Eligibility Criteria

Inclusion Criteria

•SANDE questionnaire \>40 mm
•Schirmer test without anesthesia \>2 mm and \<10mm across 5 minutes
•Tear film break-up time (TFBUT) \< 10 seconds in the worse eye
•The same eye (eligible eye) must fulfill all the above criteria
•Best corrected distance visual acuity (BCDVA) score of ≥ 0.1 decimal units (20/200 Snellen value) in both eyes at the time of study enrollment.
•If a female of childbearing potential, have a negative pregnancy test.
•Only patients who satisfy all Informed Consent requirements may be included in the study. The patient must read, sign and date the Informed Consent document before any study-related procedures are performed. The Informed Consent form signed by patients must have been approved by the Institutional Review Board (IRB) / Independent Ethics Committee (IEC) for the current study.
•Patients must have the ability and willingness to comply with study procedures.
•Patients must meet the internationally established criteria for a "probable" or "definite" diagnosis of oGVHD. As an inclusion criterion, a diagnosis of oGVHD is established from the Schirmer's 1 tear test, corneal fluorescein staining, OSDI scores, and conjunctival injection. Severity scores are assigned according to the panels provided by the International Chronic Ocular Graft-versus-Host Disease Consensus Group.
•Ability to speak and understand the English language sufficiently to understand the nature of the study, to provide written informed consent, and to allow the completion of all study assessments.

Exclusion Criteria

•Evidence of an active ocular infection, in either eye
•Presence of any other ocular disorder or condition requiring topical medication during the entire duration of study
•History of severe systemic allergy or of ocular allergy (including seasonal conjunctivitis) or chronic conjunctivitis and/or keratitis other than dry eye
•Intraocular inflammation defined as Tyndall score \>0
•Systemic disease (excluding GVHD) not stabilized within 1 month before Screening Visit (e.g. diabetes with glycemia out of range, thyroid malfunction..) or judged by the investigator to be incompatible with the study (e.g. current systemic infections) or with a condition incompatible with the frequent assessment required by the study
•Patient had a serious adverse reaction or significant hypersensitivity to any drug or chemically-related compounds or had a clinically significant allergy to drugs, foods, amide local anesthetics or other materials including commercial artificial tears (in the opinion of the investigator)
•Females of childbearing potential (those who are not surgically sterilized or post-menopausal for at least 1 year) are excluded from participation in the study if they meet any one of the following conditions:
•are currently pregnant or,
•have a positive result at the urine pregnancy test (Baseline/Day 0) or,
•intend to become pregnant during the study treatment period or,

Arms & Interventions

Treatment

Subjects receive lifitegrast 5% ophthalmic solution twice a day for 4 weeks after a 2 week washout.

Intervention: Lifitegrast 5% Ophthalmic Solution

Placebo

Subjects receive the lifitegrast vehicle as placebo twice a day for 4 weeks after a 2 week washout.

Intervention: Placebo

Outcomes

Primary Outcomes

Change from baseline in Symptoms questionnaire (SANDE) scores to Week 4

Time Frame: Baseline to Week 4

The SANDE score is calculated by taking the square root of the product of the severity of symptoms scores and the frequency of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount or absence of dry eye symptoms.