An understanding of ocular allergic disease, its incidence, demographics, and treatment paradigms provides important information towards understanding its pharmacoeconomics and burden on the national health system.

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Purpose To study the clinical effect and morphologic aspects of the cornea in using corneal confocal microscopy in patients affected by moderate to severe dry eye and treated with either autologous serum or Thealoz. Methods Twenty two patients were included and randomized in 3 groups: 7 patients (4 affected by Sjoegren Syndrome ‐SS) were switched from autologous serum eye drop treatment to Thealoz 6‐8 times a day (group 1); 7 patients (4 SS) maintained their treatment by autologous serum 6‐8 times a day (group 2); 8 new patients (3 SS) were treated by Thealoz 6‐8 times a day (group 3). The OSDI questionnaire, tear film evaluation by BUT, fluoresceine and lissamine green staining, Schirmer test and corneal confocal microscopy were performed at the beginning of the study (T0) after 4 (T1) and 8 weeks (T2). ConfoScan CS4 (Nidek, Gamagori, Japan) images of the central cornea were obtained with a 40x non‐contact lens and Z‐ring device. The epithelial cell, endothelial cell and keratocyte densities of the central cornea, the characteristics of the sub‐basal long nerve fibers and of the sub‐basal nerve plexus were studied. Results In group1, 4 of the 7 patients maintained unmodified their clinical benefit and corneal morphology after switching from autologous serum to Thealoz. Two severe SS patients needed to return to the autologous serum treatment because of worsening of the OSDI at T1 without a significant change in the other parameters. However, in remaining 5 patients, the OSDI questionnaire improved at T2 compared to T1. In group 2, all patients maintained a stable clinical and morphological ocular surface condition over the 8 weeks study period. Group 3, at T2, showed an objective improvement of ocular surface morphology and reported a significant subjective relief of symptoms (OSDI) compared to T0 and T1. All patients showed improvement of confocal microscopy parameters after treatment with Thealoz. Conclusion Thealoz was effective and well tolerated in patients with moderate to severe dry eye. Severe SS patients may need an additional treatment, however even switching from autologous serum, most of the patients maintain a stable clinical condition.