The Effects and Safety of 5% Lifitegrast Ophthalmic Solution in Subjects With Dry Eye Disease in Ocular Graft-versus-Host Disease

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 (20/200Snellen 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 thestudy. The patient must read, sign and date the Informed Consent document before anystudy-related procedures are performed. The Informed Consent form signed by patientsmust have been approved by the Institutional Review Board (IRB) / Independent EthicsCommittee (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 isestablished from the Schirmer's 1 tear test, corneal fluorescein staining, OSDIscores, and conjunctival injection. Severity scores are assigned according to thepanels provided by the International Chronic Ocular Graft-versus-Host DiseaseConsensus Group.

• Ability to speak and understand the English language sufficiently to understand thenature of the study, to provide written informed consent, and to allow thecompletion 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 medicationduring the entire duration of study

• History of severe systemic allergy or of ocular allergy (including seasonalconjunctivitis) 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 ScreeningVisit (e.g. diabetes with glycemia out of range, thyroid malfunction..) or judged bythe investigator to be incompatible with the study (e.g. current systemicinfections) or with a condition incompatible with the frequent assessment requiredby the study

• Patient had a serious adverse reaction or significant hypersensitivity to any drugor chemically-related compounds or had a clinically significant allergy to drugs,foods, amide local anesthetics or other materials including commercial artificialtears (in the opinion of the investigator)

• Females of childbearing potential (those who are not surgically sterilized orpost-menopausal for at least 1 year) are excluded from participation in the study ifthey meet any one of the following conditions:

1. are currently pregnant or,

2. have a positive result at the urine pregnancy test (Baseline/Day 0) or,

3. intend to become pregnant during the study treatment period or,

4. are breast-feeding or,

5. are not willing to use highly effective birth control measures, such as:hormonal contraceptives - oral, implanted, transdermal, or injected - and/ormechanical barrier methods - spermicide in conjunction with a barrier such as acondom or diaphragm or Intra Uterine Device (IUD) - during the entire courseof, and 30 days after, the study treatment periods

• Any concurrent medical condition, that in the judgment of the PI, might interferewith the conduct of the study, confound the interpretation of the study results, orendanger the patient's well-being

• Use of topical cyclosporine, topical corticosteroids or any other topical drug forthe treatment of dry eye in either eye within 30 days prior to study enrollment.

• Contact lenses or punctum plug use at any time 30 days prior to or during the study

• History of drug addiction or alcohol abuse

• Any prior ocular surgery (including refractive palpebral and cataract surgery) ifwithin 90 days before the screening visit

• Participation in a trial with a new active substance during the past 6 months

• Participation in another trial study at the same time as the present study.

• Previous use of lifitegrast, 5%