Ocular rosacea: an alternative treatment with 2% pilocarpine eyedrops, a randomized trial

Abstract

BACKGROUND: Ocular rosacea is a chronic inflammatory condition considered a phenotype of rosacea; however, it may also occur independently of cutaneous involvement. The more frequent symptoms are ocular irritation, foreign body sensation, itch, redness, dryness photophobia, and/or epiphora, but in more severe cases it can cause vision loss. Despite the availability of multiple therapeutic options, the condition remains incurable, relapse rates are high, and long-term current treatments can present with significant adverse events. Pilocarpine has been investigated as an effective treatment for Demodex infestation, which is associated with ocular rosacea. Moreover, we hypothesize that other muscarinic actions of pilocarpine could help improve tear quality, therefore improving ocular symptoms. This will be the first clinical trial to assess pilocarpine eyedrops for moderate ocular rosacea. OBJECTIVES: The main objective is to evaluate whether pilocarpine ophthalmic solution provides superior efficacy compared with placebo, assessed by tear break-up time, when added to standard conservative treatment, in patients with moderate ocular rosacea. Secondary efficacy outcomes include Oxford staining grading, meibography assessment, Demodex concentration and Ocular Surface Disease Index. We will also determine the correlation between TBUT efficacy and Demodex concentration. DESIGN AND SETTING: This is a multicenter, randomized, triple-blind, placebocontrolled, paired-eye, superiority 6-month clinical trial. It will be conducted across four hospitals in Catalonia. PARTICIPANTS AND METHODS: The study population will consist of moderate ocular rosacea following the global ROSacea Consesus and National Rosacea Society criteria, aged 18 years or older. A total of 96 participants will be enrolled based on predefined inclusion and exclusion criteria. Each participant will, via centralized computer-generated randomization sequence, receive topical pilocarpine 2% in one eye and placebo in the contralateral eye. Both eyes will receive conservative treatment based on artificial tears, digital massage, eyelid hygiene, warm compress and avoidance of known triggers

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