Ahmed Hamed Rehan, Hassan El-Masry, Roaa Abdultawab, Manahil Ahmed, Rawan Ashraf Kasem, Mohammad Al Diab Al Azzawi, Shree Rath
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Abstract
Background: Dry eye disease (DED) is a widely prevalent ocular symptom, with an estimated global prevalence of around 12%. The increasing prevalence of this disease among adults poses a significant morbidity burden. The aim of this study is to analyze the efficacy and safety of water-free cyclosporine, a new intervention suggested to be more effective in treating DED.
Methods: A comprehensive literature search was conducted using databases as PubMed, Cochrane, Scopus and Web of Science. Keywords used include "dry eye", "water-free cyclosporine", and "DED" among others. Randomized controlled trials (RCTs) evaluating the use of water-free cyclosporine in patients with dry eye disease were included.
Results: A total of 4 RCTs were included in our analysis, consisting of 1,471 participants. Primarily, efficacy outcomes were evaluated such as total and central corneal fluorescence staining score (tCFS and cCFS) and dryness score. Our secondary outcomes evaluated the safety of these drugs by considering the treatment-emergent adverse events (TEAEs) reported. Water-Free cyclosporine showed no significant improvement in tCFS (MD: -1.08; 95% CI, -3.48 to 1.32) and cCFS (MD: -0.21, 95% CI, -0.50 to 0.08). However, water free cyclosporine showed statistically and clinically significant results in improving the dryness score (MD, -7.48; 95% CI, -14.5 to -.082). Pooled analysis of total participants reporting TEAEs, ocular and serious TEAEs was not significant.
Conclusion: Our meta-analysis analyzed the safety and efficacy of water-free topical 0.1% cyclosporine eye drops for the treatment of moderate to severe DED. A significant reduction in dryness scores provides hope for further development of this drug, potentiated with the little to no significant increase in risk of adverse events. There is a need for diverse trials with a greater population to validate these results and generate rigorous evidence.
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