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Integrin antagonist

Lifitegrast 5% Ophthalmic Solution for Graft-versus-Host Disease

Phase < 1
Recruiting
Research Sponsored by Richard W Yee, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 4
Awards & highlights

Study Summary

This trial will compare the efficacy of a new eye drop for treating dry eye disease caused by Graft-versus-Host Disease to the current standard of care.

Eligible Conditions
  • Graft-versus-Host Disease
  • Graft Versus Host Disease of the Eye

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in Symptoms questionnaire (SANDE) scores to Week 4
Secondary outcome measures
Change from baseline in Schirmer I test (without anesthesia) to Week 4
Other outcome measures
Change from baseline in Symptoms questionnaire (SANDE) scores for frequency to Week 4
Change from baseline in Tear Film Break-Up Time (TFBUT) to Week 4
Change from baseline in conjunctiva vital staining with lissamine green to Week 4
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment1 Intervention
Subjects receive lifitegrast 5% ophthalmic solution twice a day for 4 weeks after a 2 week washout.
Group II: PlaceboPlacebo Group1 Intervention
Subjects receive the lifitegrast vehicle as placebo twice a day for 4 weeks after a 2 week washout.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lifitegrast 5% Ophthalmic Solution
2021
Completed Phase 4
~490

Find a Location

Who is running the clinical trial?

NovartisIndustry Sponsor
1,614 Previous Clinical Trials
2,721,364 Total Patients Enrolled
Novartis PharmaceuticalsIndustry Sponsor
2,866 Previous Clinical Trials
4,199,296 Total Patients Enrolled
1 Trials studying Graft-versus-Host Disease
127 Patients Enrolled for Graft-versus-Host Disease
Richard W Yee, MDLead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

Lifitegrast 5% Ophthalmic Solution (Integrin antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04792580 — Phase < 1
Graft-versus-Host Disease Research Study Groups: Placebo, Treatment
Graft-versus-Host Disease Clinical Trial 2023: Lifitegrast 5% Ophthalmic Solution Highlights & Side Effects. Trial Name: NCT04792580 — Phase < 1
Lifitegrast 5% Ophthalmic Solution (Integrin antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04792580 — Phase < 1
~12 spots leftby Jun 2025
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