This is a multi-center, double-masked, randomized, placebo-controlled, parallel-group, efficacy, safety, and tolerability study evaluating the efficacy of Dupilumab in the treatment of signs and symptoms of atopic keratoconjunctivitis (AKC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
42
monoclonal antibody
Premiere Practice Management, LLC
Los Angeles, California, United States
Percentage of treatment responders
• Determination of the percentage of treatment responders as defined as meeting one or more of the below at the end of the 16-week treatment period (Visit 7) as compared to Visit 2 (baseline): * ≥ 1 grade improvement in lid margin redness (0-3 scale, NOT allowing half unit increments) * ≥ 1 grade improvement in lid excoriation (0-3 scale, NOT allowing half unit increments) * ≥ 1 grade improvement in lid thickening/lichenification (0-3 scale, NOT allowing half unit increments) * ≥ 1 grade improvement in changes in mucocutaneous junction (0-3 scale, NOT allowing half unit increments) * ≥ 4 grade improvement in a composite symptom score (the sum of scores for ocular itching, tearing/watery eyes, ocular discomfort, photophobia, and nonpurulent mucous discharge) * \>2 grade improvement in an individual symptom from Visit 2 (baseline)
Time frame: Baseline to Week 16
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Colorado Eye Consultants/Corneal Consultants of Colorado
Littleton, Colorado, United States
RECRUITINGEncore Medical Research, LLC
Hollywood, Florida, United States
COMPLETEDKannar Eye Care
Pittsburg, Kansas, United States
RECRUITINGAndover Eye Associates
Andover, Massachusetts, United States
RECRUITINGUniversity of Michigan- Kellogg Eye Center
Ann Arbor, Michigan, United States
WITHDRAWNSilverstein Eye Centers
Kansas City, Missouri, United States
RECRUITINGMercy Clinic Eye Specialists
Springfield, Missouri, United States
RECRUITINGOphthalmology Associates
St Louis, Missouri, United States
RECRUITINGSt. Louis Eye Institute
Town and Country, Missouri, United States
RECRUITING...and 10 more locations