dc.description.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
