Evaluation of unpreserved dexamethasone phosphate 0.1% versus placebo in patients with severe keratoconjunctivitis sicca (KCS) due to Sjögren's syndrome (SS)

Purpose KCS in SS is often associated with chronic inflammation. Moreover epithelial damage induces a release of local prostaglandins. Corticosteroids are potent inhibitors of many inflammatory pathways. Methods 21 patients were included in a double masked, intra‐individual comparison versus placebo, in patients with bilateral severe KCS due to SS. One drop of dexamethasone 0.1% was instilled in one eye tid during the first week of the study, bid during the following 2 weeks and qd during the last 2 weeks. One drop of placebo was instilled in the contra‐lateral eye with the same schedule. Patients attended 3 visits: D0, D7 and D35. A phone call was made on D70 to collect AEs and assess ocular discomfort. Symptomatology within the last 48h was evaluated on a VAS. Ocular symptoms and signs and safety were recorded at each visit. Results Both treatments resulted in a decrease of the patient’s ocular discomfort. At Day 35, a significant difference was found between the two treatments for the patient’s feeling of ocular discomfort, with better values under dexamethasone (p=0.007). No significant difference between treatments was observed on signs. But, the difference in Lissamine green total score between the 2 treatments almost reached statistical significance in favour of dexamethasone on D7 (p=0.056) and conjunctival hyperaemia improved faster with dexamethasone, as soon as D7. Investigators seemed to be more satisfied by the dexamethasone treatment both on Day 7 and Day 35. No statistically significant difference in overall tolerance assessments was observed between the two treatment groups. Conclusion Unpreserved dexamethasone 0.1% eye drops improve symptoms and signs due to KCS in SS.