Lacrimal gland botulinum toxin injection for chronic epiphora in patients with anatomical or functional nasolacrimal duct obstruction: A randomised, double-blinded, placebo-controlled, crossover trial using subjective endpoints.

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Epiphora, or excessive watering of the eye, is a distressing symptom of nasolacrimal duct obstruction. It can lead to significant reduction in quality of life and cause social embarrassment. Current treatment options, such as dacryocystorhinostomy, are surgically invasive and carry a small risk or morbidity. Botulinum toxin injection into the lacrimal gland is a promising treatment for epiphora in patients with nasolacrimal duct obstruction who refuse, or are not fit for surgery. It can be offered in an outpatient setting and published case series suggest that this treatment is safe and effective. However, there is currently a lack of randomised, controlled trials to support its routine use in patients with nasolacrimal duct obstruction. The proposed study will be the first of its kind to systematically evaluate botulinum toxin as a treatment for epiphora in patients with nasolacrimal duct obstruction. We propose a randomised, double-blinded, placebo-controlled, crossover trial. Patients will be randomised to receive an injection of either botulinum toxin or placebo (normal saline) initially, and 6 months later they will cross over treatments. We will perform phone follow-up interviews to assess change in subjective measures of epiphora symptoms and complication rates. Our hypothesis is that lacrimal gland botulinum toxin injection will significantly reduce subjective symptoms of chronic epiphora in patients with nasolacrimal duct obstruction as compared to placebo.

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