CompletedEarly Phase 1

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

United States30 participantsStarted 2022-10-22

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

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Exclusion criteria

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

What they're measuring

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

Timeframe: Baseline to Week 4

Trial details

NCT IDNCT04792580

SponsorRichard W Yee, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-30

View on ClinicalTrials.gov More Graft-versus-host-disease trials