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Lifitegrast 5% Ophthalmic Solution for Graft Versus Host Disease of the Eye

Richard W Yee, MD PLLC, Bellaire, TX
Graft Versus Host Disease of the Eye+1 More ConditionsLifitegrast 5% Ophthalmic Solution - Drug
Eligibility
18 - 85
All Sexes
What conditions do you have?
Select

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 (GVHD) of the Eye
  • Graft-versus-Host Disease

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase < 1

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0.3% YP-P10 Ophthalmic Solution
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Doxycycline Injection [Doxy]

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Baseline to Week 4

Baseline to Week 4
Change from baseline in Schirmer I test (without anesthesia) to Week 4
Change from baseline in Symptoms questionnaire (SANDE) scores for frequency to Week 4
Change from baseline in Symptoms questionnaire (SANDE) scores 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
Change in Corneal Staining Score from baseline to Week 4
Change in OSDI score from baseline to Week 4

Trial Safety

Phase-Based Safety

1 of 3

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2
TL-925 Arm
2
0.3% YP-P10 Ophthalmic Solution
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Doxycycline Injection [Doxy]

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

3 Treatment Groups

Standard of Care
1 of 3
Treatment
1 of 3
Placebo
1 of 3

Active Control

Experimental Treatment

Non-Treatment Group

30 Total Participants · 3 Treatment Groups

Primary Treatment: Lifitegrast 5% Ophthalmic Solution · Has Placebo Group · Phase < 1

Treatment
Drug
Experimental Group · 1 Intervention: Lifitegrast 5% Ophthalmic Solution · Intervention Types: Drug
Standard of Care
Drug
ActiveComparator Group · 1 Intervention: Refresh · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lifitegrast
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to week 4

Who is running the clinical trial?

NovartisIndustry Sponsor
1,593 Previous Clinical Trials
2,706,289 Total Patients Enrolled
Novartis PharmaceuticalsIndustry Sponsor
2,771 Previous Clinical Trials
3,830,204 Total Patients Enrolled
Richard W Yee, MDLead Sponsor

Eligibility Criteria

Age 18 - 85 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You scored more than 40 mm on the SANDE questionnaire.
The eye being considered for the study must meet all the requirements listed.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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