ICY-AKC-301 (TRAK) - Clinical Trial
What is the Purpose of this Study?
Study visits at week 0, 4, 6, 8, and 12
What is the Condition Being Studied?
Atopic keratoconjunctivitis (AKC) which is an allergic condition that causes red, itchy, watery eyes
Who Can Participate in the Study?
Participants with active AKC with symptoms of itching and eye redness
Age Group
Adults
What is Involved?
This study wants to find out if an eye medicine called DFL24498 is safe and works well. People in the study will put one drop of the medicine in each eye four times a day for twelve weeks. Some people will get the real medicine, and others will get a liquid with no medicine in it, so the researchers can compare how well each one works.
Study Details
Full Title
A Phase 3, Multicenter, Randomized, Double-Masked, Vehicle-Controlled Study to Demonstrate Efficacy and Safety of DFL24498 Eye Drop Solution in Adult Participants with Atopic Keratoconjunctivitis (AKC) - TRAK
Principal Investigator
Amol A. Sura, MD
Ophthalmologist
Protocol Number
IRB:
PRO00119397
NCT:
NCT07395232
Phase
Phase III
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment