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Integrin antagonist

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

Q: Does this clinical trial encompass participants who are over the age of 60?

As per the conditions of this trial, those who meet its requirements must be aged 18 or older and 85 or younger.

Q: How many individuals have registered for the research endeavor?

Yes, clinicaltrials.gov indicates that this medical trial is currently in the recruitment phase. The study was first published on October 22nd 2022 and has since been updated as recent as November 11th 2022. Thirty patients are needed to be enrolled from 1 centre.

Q: Are there any vacancies available in this trial for participants?

Per clinicaltrials.gov, this trial is recruiting as of now and was initially posted on October 22nd 2022. The most recent edit to the posting occurred last month on November 11th 20202.

Q: Is this an unprecedented research endeavor?

Lifitegrast 5% Ophthalmic Solution has been on the research radar since 2022, when Novartis sponsored its first clinical trial with 30 participants. Subsequently, Lifitegrast 5% Ophthalmic Solution met Phase 1 drug approval standards and currently there is one active study being conducted under the sponsorship of Novartis.

Q: Am I eligible for participation in this research study?

To partake in this medical trial, applicants must have keratoconjunctivitis sicca and be within the age range of 18 to 85. A total of 30 patients are being sought for enrollment.

Q: Are there any prior trials involving Lifitegrast 5% Ophthalmic Solution that we should be aware of?

Presently, one clinical trial is underway to investigate the efficacy of Lifitegrast 5% Ophthalmic Solution and has progressed to Phase 3. A single medical centre in Bellaire, <a href="https://www.withpower.com/clinical-trials/texas">Texas</a> is running the trials on this drug with no other sites involved.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 4

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

NovartisIndustry Sponsor

1,611 Previous Clinical Trials

2,721,005 Total Patients Enrolled

Novartis PharmaceuticalsIndustry Sponsor

2,862 Previous Clinical Trials

4,198,457 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial encompass participants who are over the age of 60?

"As per the conditions of this trial, those who meet its requirements must be aged 18 or older and 85 or younger."

Answered by AI

How many individuals have registered for the research endeavor?

"Yes, clinicaltrials.gov indicates that this medical trial is currently in the recruitment phase. The study was first published on October 22nd 2022 and has since been updated as recent as November 11th 2022. Thirty patients are needed to be enrolled from 1 centre."

Answered by AI

Are there any vacancies available in this trial for participants?

"Per clinicaltrials.gov, this trial is recruiting as of now and was initially posted on October 22nd 2022. The most recent edit to the posting occurred last month on November 11th 20202."

Answered by AI

Is this an unprecedented research endeavor?

"Lifitegrast 5% Ophthalmic Solution has been on the research radar since 2022, when Novartis sponsored its first clinical trial with 30 participants. Subsequently, Lifitegrast 5% Ophthalmic Solution met Phase 1 drug approval standards and currently there is one active study being conducted under the sponsorship of Novartis."

Answered by AI

Am I eligible for participation in this research study?

"To partake in this medical trial, applicants must have keratoconjunctivitis sicca and be within the age range of 18 to 85. A total of 30 patients are being sought for enrollment."

Answered by AI

Are there any prior trials involving Lifitegrast 5% Ophthalmic Solution that we should be aware of?

"Presently, one clinical trial is underway to investigate the efficacy of Lifitegrast 5% Ophthalmic Solution and has progressed to Phase 3. A single medical centre in Bellaire, Texas is running the trials on this drug with no other sites involved."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Richard W Yee, MD 2022. "The Effects and Safety of 5% Lifitegrast Ophthalmic Solution in Subjects With Dry Eye Disease in Ocular Graft-versus-Host Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04792580.

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