Lifitegrast for Dry Eye Syndrome

((IVCM) Trial)

MT
RT
Overseen ByRolando Toyos, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of Lifitegrast Ophthalmic Solution 5.0% (an eye drop medication) for individuals with Dry Eye Disease. Researchers aim to assess its effects on the eyes using a special microscope to examine eye cells closely. The trial suits those who have experienced dry eyes for at least six months and can refrain from wearing contact lenses during the study. As a Phase 4 trial, this research seeks to understand how this FDA-approved and effective treatment benefits a broader range of patients.

Do I have to stop taking my current medications for the trial?

Yes, you may need to stop certain medications. The trial requires that you do not use topical steroids, systemic immunosuppressive agents, or certain other medications during the study. If you have changed any systemic medication within 30 days before screening, you may not be eligible.

What is the safety track record for Lifitegrast Ophthalmic Solution 5.0%?

Research has shown that Xiidra, a 5.0% eye drop solution, is safe for treating dry eye disease. Studies have found that patients generally tolerate Xiidra well. In over seven years of global use, no new safety issues have emerged. Most side effects are mild, such as eye irritation or a strange taste, and rarely lead to discontinuation. Xiidra received U.S. approval in 2016, further supporting its safety for treating dry eye symptoms.12345

Why are researchers enthusiastic about this study treatment?

Lifitegrast is unique because it targets a specific molecule called LFA-1, which plays a key role in the inflammation associated with dry eye syndrome. Unlike traditional treatments like artificial tears or anti-inflammatory drugs such as cyclosporine, Lifitegrast directly blocks the interaction between LFA-1 and ICAM-1, thereby reducing inflammation at the cellular level. Researchers are excited about this treatment's potential to offer a more targeted approach with faster relief of symptoms for those suffering from dry eye syndrome.

What is the effectiveness track record for Lifitegrast in treating Dry Eye Syndrome?

Studies have shown that Lifitegrast Eye Drops 5.0% effectively treat dry eye disease, significantly reducing symptoms like dryness and discomfort. Research indicates that they also improve the condition of the eye's surface. Patients reported noticeable relief within 1 to 3 months of using the drops. Overall, Lifitegrast is considered a safe and reliable treatment for dry eye disease, providing lasting improvements over time.12678

Who Is on the Research Team?

MT

Melissa Toyos, MD

Principal Investigator

West Tennessee Eyecare dba Toyos Clinic

RT

Rolando Toyos, MD

Principal Investigator

West Tennessee Eyecare dca Toyos Clinic

Are You a Good Fit for This Trial?

This trial is for adults 18 or older with a history of dry eye for at least 6 months, certain test results showing moderate dryness, and good vision (20/100 or better). Participants must be willing to follow study rules. Women of childbearing age must use effective birth control.

Inclusion Criteria

I am postmenopausal or have had surgery to remove my uterus or both ovaries.
* 1\. Subject can read, understand and sign an informed consent letter. 2. Provision of signed and dated informed consent form and HIPAA authorization. 3. Stated willingness to comply with all study procedures and availability for the duration of the study 4. Male or female at least 18 years of age at the time of enrollment 5. Minimum corneal staining of ≥2 or greater according to the NEI grading scale in the lower corneal subregion.
Normal eyelids and corneal anatomy 7. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of study drug administration 8.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Lifitegrast Ophthalmic Solution 5.0% (Xiidra) for dry eye disease

12 weeks
Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Lifitegrast Ophthalmic Solution 5.0%

Trial Overview

The study tests Lifitegrast Ophthalmic Solution 5.0% (Xiidra) eye drops in people with dry eye disease. It uses special imaging to see how the treatment affects the eyes over time. All participants receive the same treatment.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: DED subjects treated with lifitegrast ophthalmic solution 5.0% (Xiidra)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Toyos Clinic

Lead Sponsor

Trials
9
Recruited
260+

Citations

Efficacy of Lifitegrast Ophthalmic Solution, 5.0%, in Patients ...

The results of this post hoc analysis suggest that lifitegrast treatment may be associated with a response in the signs and symptoms of moderate to severe DED.

2.

xiidra-ecp.com

xiidra-ecp.com/efficacy/

The Impact of Xiidra® (lifitegrast ophthalmic solution) 5%

Significant and sustained improvement vs baseline in symptoms · Significant Improvement in Signs vs Baseline in Ocular Surface Quality · HAD NO CORNEAL STAINING

Lifitegrast Ophthalmic Solution 5% Is a Safe and Efficient ...

In the meta-analysis, lifitegrast was superior to the placebo because it improved TCSS, NLSS, TBUT, ODS, eye discomfort score, EDS, and OSDI-Sin ...

208073Orig1s000 - accessdata.fda.gov

The application does not provide substantial evidence of efficacy for lifitegrast ophthalmic solution, 5%, in the treatment of dry eye disease ...

New data reinforces XIIDRA's eye dryness relief among CL ...

Open-label study evaluated effectiveness of lifitegrast 5%, noting significant improvements in end-of-day dryness and discomfort in just 2 ...

Postmarketing Analysis Confirms Safety Profile of ...

Lifitegrast ophthalmic solution 5% showed no new safety signals over seven years of postmarketing data, confirming its favorable safety profile ...

XIIDRA® prescribing information

Xiidra is a prescription eye drop solution used to treat the signs and symptoms of dry eye disease (DED). It is not known if Xiidra is safe and effective in ...

8.

xiidra-ecp.com

xiidra-ecp.com/safety/

Side Effects of Xiidra® (lifitegrast ophthalmic solution) 5%

ESTABLISHED SAFETY PROFILE. Xiidra® was well-tolerated in clinical trials, with low discontinuation rates; over 7 years of global use shows no new safety ...