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 is testing an eye drop treatment to see if it is safe and works better than inactive eye drops. Participants will use one drop in each eye four times a day for 12 weeks. Researchers will compare the results between the study treatment and the inactive eye drops.
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