RESUMEN
Background and Objectives: Mucilaginous substances from plants are known to be able to support the lubricating effect of hyaluronic acid (HA) in dry eye disease (DED). In this pilot study, the combined lubricating effect of HA and mallow extract (Malva sylvestris L.) in patients with DED was assessed. Materials and Methods: Twenty patients at five ophthalmological practices in Italy were treated with eye drops containing HA and mallow extract on the one hand, and with eye drops containing HA only, on the other hand, in a two-period crossover design. As primary endpoints, the tear film breakup time (TBUT), the reduction of lissamine green staining of the ocular surface (Oxford Scheme, OS), and the safety and efficacy assessment by the ophthalmologists were evaluated. As secondary variables, the patient symptom score, the ocular surface index (OSDI) and the satisfaction, preference and efficacy assessment by the patients were evaluated. All data were analysed descriptively in addition to an exploratory analysis being made of the target variables. Results: Both products were well-tolerated. There were no statistically significant differences with regard to the TBUT, OS and OSDI between the two treatments. Anyway, the efficacy and safety assessments by the ophthalmologists and the patients showed results in favour of the combined product. Conclusion: The addition of mallow extract to HA-containing eye drops enhances the treatment of DED, at least with respect to subjective measurements. Further assessments will have to be done to prove and explain this observation in terms of measurable parameters, e.g., markers for inflammatory cytokines.
