Efficacy of Topical Cyclosporine Nanoemulsion 0.05% Compared with Topical Cyclosporine Emulsion 0.05% and Diquafosol 3% in Dry Eye
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Purpose: To evaluate the efficacy and safety of cyclosporine nanoemulsion 0.05% compared to cyclosporine emulsion0.05% and diquafosol sodium 3%. Methods: This was a multicenter, randomized, evaluator-masked, active control, parallel, phase IV study. A total of227 patients were randomly allocated to instill cyclosporine nanoemulsion 0.05% (CN) twice daily, cyclosporineemulsion 0.05% (CE) twice daily, or diquafosol sodium 3% (DQ) six times daily. Non-inferiority of CN was analyzedby primary endpoint (cornea and conjunctival staining scores at week 12). The secondary endpoints were scoresof corneal staining, conjunctival staining, tear break-up time, Schirmer test, and Ocular Surface Disease Index atweeks 4 and 12. Results: Primary endpoints showed statistically significant improvements in all groups. Primary endpoints were -6.60for the CN group, -5.28 for the CE group, and -6.63 for the DQ group (National Eye Institute scale from 0 to 33), verifyingthe non-inferiority of CN compared to CE (95% confidence interval, -0.15 to 2.80, Δ>-2.88). In intergroup comparisonbetween CN and CE groups, the CN group had significantly more decreased conjunctival staining score atweek 12. Intergroup comparison between CN and DQ groups showed consistent statistically significant improvementsin TBUT and Schirmer test in the CN group. In the DQ group, TBUT showed late statistically significant improvementat week 12 and Schirmer test showed relatively short-term statistically significant improvement at week 4. Conclusions: Cyclosporine nanoemulsion 0.05% was equivalently efficient compared to cyclosporine emulsion 0.05%and diquafosol sodium 3%. In addition, CN showed significant improvements in several parameters for treatment ofdry eyes.
Abstract
Purpose: To evaluate the efficacy and safety of cyclosporine nanoemulsion 0.05% compared to cyclosporine emulsion0.05% and diquafosol sodium 3%. Methods: This was a multicenter, randomized, evaluator-masked, active control, parallel, phase IV study. A total of227 patients were randomly allocated to instill cyclosporine nanoemulsion 0.05% (CN) twice daily, cyclosporineemulsion 0.05% (CE) twice daily, or diquafosol sodium 3% (DQ) six times daily. Non-inferiority of CN was analyzedby primary endpoint (cornea and conjunctival staining scores at week 12). The secondary endpoints were scoresof corneal staining, conjunctival staining, tear break-up time, Schirmer test, and Ocular Surface Disease Index atweeks 4 and 12. Results: Primary endpoints showed statistically significant improvements in all groups. Primary endpoints were -6.60for the CN group, -5.28 for the CE group, and -6.63 for the DQ group (National Eye Institute scale from 0 to 33), verifyingthe non-inferiority of CN compared to CE (95% confidence interval, -0.15 to 2.80, Δ>-2.88). In intergroup comparisonbetween CN and CE groups, the CN group had significantly more decreased conjunctival staining score atweek 12. Intergroup comparison between CN and DQ groups showed consistent statistically significant improvementsin TBUT and Schirmer test in the CN group. In the DQ group, TBUT showed late statistically significant improvementat week 12 and Schirmer test showed relatively short-term statistically significant improvement at week 4. Conclusions: Cyclosporine nanoemulsion 0.05% was equivalently efficient compared to cyclosporine emulsion 0.05%and diquafosol sodium 3%. In addition, CN showed significant improvements in several parameters for treatment ofdry eyes.
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