Lifitegrast for Dry Eye Syndrome
((IVCM) 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?
Melissa Toyos, MD
Principal Investigator
West Tennessee Eyecare dba Toyos Clinic
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Lifitegrast Ophthalmic Solution 5.0% (Xiidra) for dry eye disease
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
30 subjects with DED receiving lifitegrast ophthalmic solution 5.0% (Xiidra)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Toyos Clinic
Lead Sponsor
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.
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 ...
5.
glance.eyesoneyecare.com
glance.eyesoneyecare.com/stories/2025-09-11/new-data-reinforces-xiidra-s-eye-dryness-relief-among-cl-wearers/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 ...
6.
hcplive.com
hcplive.com/view/postmarketing-analysis-confirms-safety-profile-of-lifitegrast-for-dry-eyePostmarketing 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 ...
7.
pi.bausch.com
pi.bausch.com/globalassets/pdf/packageinserts/pharma/xiidra-prescribing-information.pdfXIIDRA® 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 ...
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 ...
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