Topical interleukin 1 receptor antagonist for treatment of dry eye disease: A randomized clinical trial

Francisco Amparo, Mohammad H. Dastjerdi, Andre Okanobo, Giulio Ferrari, Leila Smaga, Pedram Hamrah, Ula Jurkunas, Debra A. Schaumberg, Reza Dana

Research output: Contribution to journalArticlepeer-review


Importance: The immunopathogenic mechanisms of dry eye disease (DED), one of the most common ophthalmic conditions, is incompletely understood. Data from this prospective, double-masked, randomized trial demonstrate that targeting interleukin 1 (IL-1) by topical application of an IL-1 antagonist is efficacious in significantly reducing DED-related patient symptoms and corneal epitheliopathy. Objective: To evaluate the safety and efficacy of treatment with the topical IL-1 receptor antagonist anakinra (Kineret; Amgen Inc) in patients having DED associated with meibomian gland dysfunction. Design and Setting: Prospective phase 1/2, randomized, double-masked, vehicle-controlled clinical trial. Participants: Seventy-five patients with refractory DED. Interventions: Participants were randomized to receive treatment with topical anakinra, 2.5% (n=30), anakinra, 5% (n=15), or vehicle (1% carboxymethylcellulose) (n=30) 3 times daily for 12 weeks. Main Outcomes and Measures: Primary outcomes were corneal fluorescein staining (CFS), complete bilateral CFS clearance, dry eye-related symptoms as measured by the Ocular Surface Disease Index, tear film breakup time, and meibomian gland secretion quality. Results: Topical anakinra was well tolerated compared with vehicle, with no reports of serious adverse reactions attributable to the therapy. After 12 weeks of therapy, participants treated with anakinra, 2.5%, achieved a 46% reduction in their mean CFS score (P =.12 compared with vehicle and P

Original languageEnglish
Pages (from-to)715-723
Number of pages9
JournalJAMA Ophthalmology
Issue number6
Publication statusPublished - Jun 2013

ASJC Scopus subject areas

  • Ophthalmology


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