Acthar Gel for Dry Eye Syndrome
(MNK Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how Acthar Gel can help individuals with dry eye syndrome and corneal pain. Participants will receive Acthar Gel injections twice a week for 12 weeks to assess its effectiveness in reducing eye pain and improving eye health. Suitable candidates include those who have experienced dry eye for at least six months, have an autoimmune disease, and find short-term relief from eye pain with specific eye drops. As a Phase 4 trial, this research aims to understand how the FDA-approved and effective Acthar Gel can benefit more patients.
Will I have to stop taking my current medications?
The trial requires that you stop using antihistamines, mast cell stabilizers, or prescription eye drops 24 hours before screening and during the study unless the dose has been stable for 14 days. Also, you should not use systemic medications known to cause dry eye unless they have been stable for at least 30 days.
What is the safety track record for Acthar Gel?
Research has shown that Acthar Gel is safe for certain eye conditions. Studies have demonstrated its effectiveness in treating severe noninfectious keratitis, a painful eye condition. This suggests it might also be well-tolerated for other eye issues, such as dry eye syndrome.
However, Acthar Gel has not been specifically tested for dry eye syndrome. It is important to note that it may have side effects similar to steroids, such as mood changes or increased blood pressure.
Since this study is in Phase 4, Acthar Gel has already received approval for other conditions, so its general safety is well understood. As always, discussing any concerns with a healthcare provider before joining a trial is advisable.12345Why are researchers enthusiastic about this study treatment?
Acthar Gel is unique because it offers a novel approach to treating dry eye syndrome. Unlike standard treatments like artificial tears or anti-inflammatory eye drops, Acthar Gel works by stimulating the body's natural production of tear film components through the adrenal cortex. This mechanism could potentially lead to more comprehensive and lasting relief for those suffering from dry eye syndrome. Researchers are excited about this treatment because it taps into the body's own healing processes, offering a different pathway to manage symptoms effectively.
What evidence suggests that Acthar Gel might be an effective treatment for dry eye syndrome?
Research has shown that Acthar Gel may help treat eye conditions like dry eye syndrome. In one study, half of the patients with keratitis, an eye condition, experienced significant improvements after using Acthar Gel for 12 weeks. Another study suggested that Acthar Gel could be a safe and effective treatment for moderate to severe dry eye disease. These findings support further exploration of its benefits for people with dry eye syndrome. Acthar Gel reduces inflammation, which may relieve symptoms such as eye pain and discomfort. Participants in this trial will receive Acthar Gel as part of an active, open-label intervention to further evaluate its effectiveness for dry eye syndrome.16789
Are You a Good Fit for This Trial?
This trial is for autoimmune patients with moderate to severe keratitis, specifically those who experience corneal pain. Participants must have dry eye syndrome and show a response to the proparacaine challenge indicating peripheral corneal pain.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 80 units of Acthar Gel injected subcutaneously twice weekly for 12 weeks using the SelfJectTM injector
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments of visual acuity, corneal and conjunctival staining
What Are the Treatments Tested in This Trial?
Interventions
- Acthar Gel
Find a Clinic Near You
Who Is Running the Clinical Trial?
Toyos Clinic
Lead Sponsor