Lacripep for Corneal Abrasion
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called Lacripep, a potential new therapy, to determine its effectiveness in healing superficial corneal injuries after PRK eye surgery. The study aims to assess the safety and effectiveness of Lacripep on eyes that have undergone this procedure. Participants will receive Lacripep in one eye and a placebo in the other. Suitable candidates for this trial include active-duty U.S. military members planning to undergo PRK for vision correction, with stable vision and no significant eye issues. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to the development of a potentially beneficial therapy.
Will I have to stop taking my current medications?
You may need to stop taking certain medications that could affect healing, like corticosteroids, isotretinoin, amiodarone, and sumatriptan. Other medications in the same family as sumatriptan are allowed, but it's best to discuss your specific medications with the study team.
Is there any evidence suggesting that Lacripep is likely to be safe for humans?
Research has shown that Lacripep has been tested for safety in other conditions. In a study with patients who have primary Sjögren syndrome, Lacripep proved to be safe and well-tolerated when applied to the skin. This indicates that using Lacripep on the eyes did not cause significant irritation or harm in those patients.
Additionally, animal tests demonstrated that Lacripep helped restore normal tear production without causing irritation, suggesting it might be gentle on the eyes.
Since the current trial is in Phase 2, earlier studies (Phase 1) found it safe enough to continue testing. While this is encouraging, the current study will provide more information on how people respond to it after eye surgery.12345Why do researchers think this study treatment might be promising?
Lacripep is unique because it is a peptide treatment specifically designed to promote healing in corneal abrasions by mimicking the natural proteins in tears. Unlike the standard treatments such as antibiotics or lubricating eye drops that primarily alleviate symptoms and prevent infection, Lacripep targets the underlying healing process directly. Researchers are excited about Lacripep's potential to accelerate healing and improve outcomes for patients with corneal abrasions by enhancing the body's natural repair mechanisms.
What evidence suggests that Lacripep might be an effective treatment for corneal abrasion?
Studies have shown that Lacripep helps heal the cornea, the clear front part of the eye. Research suggests that Lacripep repairs corneal nerves and improves overall eye health. In earlier studies, patients noticed quick improvements in corneal health and a decrease in symptoms within just two weeks. These findings suggest that Lacripep could be useful for treating minor corneal injuries, such as those occurring after eye surgeries like PRK. While more information is needed, the early results are promising.13467
Who Is on the Research Team?
Zachary P Skurski, DO
Principal Investigator
Alexander T. Augusta Military Medical Center
Are You a Good Fit for This Trial?
This trial is for U.S. military service members aged 21 or older seeking refractive correction for mild to moderate myopia, with stable vision over the past year and good eye health. Participants must be able to attend follow-ups for up to six months after PRK surgery.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Lacripep in one eye and placebo in the other eye for corneal wound healing
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lacripep
Find a Clinic Near You
Who Is Running the Clinical Trial?
Henry M. Jackson Foundation for the Advancement of Military Medicine
Lead Sponsor
TearSolutions, Inc.
Industry Sponsor
Walter Reed National Military Medical Center
Collaborator