CLINICAL TRIAL

Lifitegrast 5% Ophthalmic Solution for Dry Eye

Waitlist Available · 18+ · All Sexes · Bellaire, TX

This study is evaluating whether a new eye drop may help improve dry eye disease for individuals who have had a bone marrow transplant.

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About the trial for Dry Eye

Eligible Conditions
Dry Eye Syndromes · Graft-versus-host-disease · Graft vs Host Disease · Eye Diseases · Ocular Graft Versus Host Disease · Keratoconjunctivitis Sicca

Treatment Groups

This trial involves 2 different treatments. Lifitegrast 5% Ophthalmic Solution is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Lifitegrast 5% Ophthalmic Solution
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
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DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lifitegrast
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
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 (20/200 Snellen 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 the study. The patient must read, sign and date the Informed Consent document before any study-related procedures are performed. The Informed Consent form signed by patients must have been approved by the Institutional Review Board (IRB) / Independent Ethics Committee (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 is established from the Schirmer's 1 tear test, corneal fluorescein staining, OSDI scores, and conjunctival injection. Severity scores are assigned according to the panels provided by the International Chronic Ocular Graft-versus-Host Disease Consensus Group.
Ability to speak and understand the English language sufficiently to understand the nature of the study, to provide written informed consent, and to allow the completion of all study assessments.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline to Week 4
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline to Week 4
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline to Week 4.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Lifitegrast 5% Ophthalmic Solution will improve 1 primary outcome, 1 secondary outcome, and 5 other outcomes in patients with Dry Eye. Measurement will happen over the course of Baseline to Week 4.

Change from baseline in Symptoms questionnaire (SANDE) scores for frequency to Week 4
BASELINE TO WEEK 4
The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score. Each of the two scores ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptom. The endpoint here is the SANDE sub-score for frequency.
BASELINE TO WEEK 4
Change from baseline in conjunctiva vital staining with lissamine green to Week 4
BASELINE TO WEEK 4
The Oxford scheme is used for grading the scale of conjunctival damage. Briefly, the observer grades the extent of staining across temporal, nasal and central zones between 0 to 5, with 0 representing no staining and 5 representing severe/maximal staining.
BASELINE TO WEEK 4
Change from baseline in Schirmer I test (without anesthesia) to Week 4
BASELINE TO WEEK 4
Without previously instilling anesthetic drops, the Schirmer strip will be inserted into the lower conjunctival sac at the junction of the lateral and middle thirds, avoiding contact with the cornea. The patients will be instructed to close their eyes gently. After 5 minutes have elapsed, the Schirmer test strip will be removed and the length of the tear absorption on the strip will be measured (millimeters/5 minutes)
BASELINE TO WEEK 4
Change in Corneal Staining Score from baseline to Week 4
BASELINE TO WEEK 4
Corneal staining with fluorescein is measured from 0-3 by the NEI grading scale in any one eye region.
BASELINE TO WEEK 4
Change from baseline in Symptoms questionnaire (SANDE) scores to Week 4
BASELINE TO WEEK 4
The SANDE score is calculated by taking the square root of the product of the severity of symptoms scores and the frequency of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount or absence of dry eye symptoms.
BASELINE TO WEEK 4
Change in OSDI score from baseline to Week 4
BASELINE TO WEEK 4
The Ocular Surface Disease Index score is a 12-item questionnaire designed to survey the dry eye symptomatology of a given patient. In this case, OSDI will be used to assess whether the study drug affects specific symptoms of dry eye more than others. In other words, OSDI may be used to determine whether patients on the study drug see improvement of gritty sensations, sensitivity to light or burning sensations.
BASELINE TO WEEK 4
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Patient Q & A Section

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

What is dry eye?

In this population, tear film disruption and tear meniscus thickness were measured. The median tear meniscus thickness was 0.7mm and the tear film break-up time was 10 seconds. This was significantly lower (p<0.0001) than in tear-film evaluation groups and lower than the average tear meniscus thickness seen in normal eyes. Only a weak relationship was seen between tear film disruption and tear meniscus thickness.

Anonymous Patient Answer

What causes dry eye?

The cause of dry eye is poorly understood. The condition may be more common in women and associated with aging. There may also be a genetic component. The management and diagnosis of dry eye is also challenging.

Anonymous Patient Answer

How many people get dry eye a year in the United States?

The prevalence of dry eye in the United States is 1 to 2% among the general general population and is much higher among women aged over 70 years.

Anonymous Patient Answer

What are the signs of dry eye?

Symptoms that are associated with dry eye include itchiness and irritation, tearing and swelling of the eyes, a feeling of burning in the eyes, blurry vision and pain. The signs of dry eye include blurred vision, tearing, redness, tearing, swelling, and dry mucosa and superficial punctate keratopathy. It is difficult to identify these signs through assessment alone. A complete eye examination helps to identify the most common presenting signs of dry eye. Dry eye can be treated with appropriate topical or systemic treatment, and it can be prevented with tear production stimulating agents.

Anonymous Patient Answer

What are common treatments for dry eye?

The most common treatments for dry eye are hydrogel contact lenses and artificial tears. In more severe cases, more expensive and lengthy alternatives arise such as punctal plugs.

Anonymous Patient Answer

Can dry eye be cured?

The long-term effects of dry eye (dysfunction of the eye that causes blurred vision, tearing, and corneal edema) may not be fully reversible. However, most cases resolve satisfactorily with prolonged eye lubricants or surgery.

Anonymous Patient Answer

What is lifitegrast 5% ophthalmic solution?

The 5% product contains lifitegrast, a new topical treatment for dry eye that is FDA approved for such indications. Specifically, lifitegrast has ocular hypotensive properties, resulting in reduced fluid outflow in the aqueous and aqueous-vitreous systems. These properties contribute to the clinical benefits of lifitegrast therapy for dry eye diseases. The FDA approved the product for the treatment of dry eye and for the mitigation of ocular hypotensive symptoms for patients with glaucoma. The indications have the same restrictions found among other ophthalmic topical medications which are medically approved for the condition of dry eye.

Anonymous Patient Answer

Is lifitegrast 5% ophthalmic solution typically used in combination with any other treatments?

Lifitegrast 5% may be used as monotherapy. Lifitegrast 5% may optionally be used in combination with other topical treatments that have shown some positive effects on dry eye. More studies are needed to find out if these combinations are more effective in dry eye resolution than treatment with only one of these modalities.

Anonymous Patient Answer

Has lifitegrast 5% ophthalmic solution proven to be more effective than a placebo?

Results from a recent paper suggest lifitegrast with 5% is more effective as a treatment than a placebo for mild to moderate dry eye symptoms. This treatment regimen had acceptable safety.

Anonymous Patient Answer

What is the latest research for dry eye?

There are many studies that are new in the field of dry eye; this is a growing area of research. However, there are no medications that can help dry eye. This research will help us to understand more about this debilitating disease in the future. It is just the beginning\n

Anonymous Patient Answer

What does lifitegrast 5% ophthalmic solution usually treat?

Lifitegrast 5% ophthalmic solution is an effective and well-tolerated treatment for meibomian gland dysfunction, particularly in patients reporting meibomian gland symptoms despite using meibomian gland stimulating drops at baseline.

Anonymous Patient Answer
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