Abstract - Euphrasia D3 eye drops in children
Efficacy and safety of WELEDA Euphrasia D3 eye drops in children with catarrhal or allergic conjunctivitis – a prospective multicentre observational study

By:Michael Toelg, Mediveritas, Institute for Medical Studies, Munich
Original title: Anwendungsbeobachtung zur Wirksamkeit und Verträglichkeit von WELEDA Euphrasia D3 Augentropfen bei Kindern mit katarrhalischer oder allergischer Bindehautentzündung. Der Merkurstab 2005;58(1):43-57.
DOI: https://doi.org/10.14271/DMS-18616-DE
This translation is published with the kind permission of the journal Der Merkurstab.

Aim: To assess efficacy and safety of WELEDA Euphrasia D3 eye drops in children with catarrhal or allergic conjunctivitis.

Methods: 121 children and adolescents up to the age of 16 received Euphrasia D3 eye drops either three times daily (1 drop per eye) or according to individual prescription by their physician. Before treatment and after up to 14 days, the progress of the catarrhal or allergic conjunctivitis was evaluated on the basis of 6 symptoms: conjunctival redness, eyelid swelling, purulent secretion, sticky eyes, burning/itching and foreign body sensation; intensity of
symptoms was classified according to a scale ranging from 0 (absent) to 3 (severe). For each symptom, mean values (symptom scores) before and after treatment were calculated. Duration of treatment until noticeable improvement and assessments of efficacy and safety by the physician as well as the patient/parent were recorded.

Results: 60% of patients were female, 40% male. Their age ranged from 6 days to 16 years (mean value 7 years). 

Most frequently, the diagnoses were infectious conjunctivitis (in 65% of patients) and allergy (26%; multiple answers were possible). On average, the symptoms had persisted for 3 days before onset of treatment. 

Main concomitant diseases were rhinitis (40%), flu (39%), allergic rhinitis (14%) and other allergies (13%). 81% of patients received the recommended dose of 3x1 drops daily. On average, the patients were observed for 10 days. For each of the 6 symptoms, definite improvement could be demonstrated. 

Based on the number of patients reporting symptoms of at least mild intensity at the beginning, the percentages of patients reporting absence of symptoms at the end of treatment were: conjunctival redness: 66%; eyelid swelling: 83%; purulent secretion: 90%; sticky eyes: 85%; burning/itching: 81% and foreign body sensation: 90%. 119 patients (98%) rated themselves or were rated by their parents as symptom-free or nearly symptom-free. 

On average, a noticeable improvement was observed after 5 days of treatment. For each patient, a score was computed based on intensities for all 6 symptoms. Before treatment, the score was 9.4; after treatment it was reduced to 1.1 (mean values); in 58% of patients no symptoms persisted (score = 0). One adverse event was reported (eye irritation after administration of drops). 95% of physicians and 93% of patients/parents rated efficacy as “very good” or “good”; safety was rated “very good” or “good” by all physicians and by 99% of patients/parents.

Conclusion: The results demonstrate efficacy and safety of treatment with WELEDA Euphrasia D3 eye drops in children with catarrhal or allergic conjunctivitis.