Preclinical Efficacy Comparison of Cyclosporine Ophthalmic Solution 0.09% vs Cyclosporine Ophthalmic Emulsion 0.05% vs Ciclosporin Ophthalmic Emulsion 0.1% in a NOD Mouse Model of Dry Eye Disease

Figures & data

Figure 1 Study design.

Abbreviations: IL, interleukin; PAS, periodic acid Schiff.

Table 1 Phenol Red-Impregnated Thread Wetting Length (mm) in Both Eyes from Baseline to Day 60

Dose Groups	Day −1	Day 15	Day 30	Day 45	Day 60
C57Bl6/J normal control	4.8 ± 2.2	6.7 ± 2.0	7.1 ± 3.5	8.3 ± 3.2	13.3 ± 2.3
NOD diseased control	4.9 ± 1.6	5.4 ± 1.7	5.2 ± 1.9	6.1 ± 2.9	7.1 ± 1.4
Placebo twice daily	4.9 ± 1.3	5.6 ± 1.4	6.7 ± 2.7	7.7 ± 3.6	7.5 ± 2.3
Cyclosporine ophthalmic solution 0.09% twice daily	5.0 ± 1.3	7.9 ± 3.5	10.0 ± 4.2^#†††§§	11.5 ± 3.1^###†††§§	12.9 ± 4.5^###†††§§§ǂ
Cyclosporine ophthalmic solution 0.09% once daily	4.7 ± 1.0	6.4 ± 1.6	9.2 ± 2.5^†††	10.3 ± 3.1^#†††	11.3 ± 2.7^†††§§
Cyclosporine ophthalmic emulsion 0.05% twice daily	4.7 ± 1.2	5.8 ± 1.0	7.1 ± 1.3	7.1 ± 2.7	8.8 ± 2.4
Ciclosporin ophthalmic emulsion 0.1% once daily	4.7 ± 1.2	7.0 ± 2.5	9.1 ± 2.0^††	9.2 ± 2.6^†	9.8 ± 2.0^†

Notes: Data are shown as mean ± SD (mm). N = 11 mice and 22 eyes per study group. Values shown as mean for both eyes. # P<0.05, ### P<0.001 vs cyclosporine ophthalmic emulsion 0.05%; † P<0.05, †† P<0.01, ††† P<0.001 vs NOD diseased control; §§ P<0.01, §§§ P<0.001 vs placebo. ǂ P<0.05 vs ciclosporin ophthalmic emulsion 0.1%.

Abbreviations: NOD, NOD.B10.H2^b; SD, standard deviation.

Figure 2 Change from baseline in tear production through 60 days of treatment.

Notes: # P <0.05, ## P <0.01 vs cyclosporine ophthalmic emulsion 0.05%; † P <0.05, †† P <0.01, ††† P <0.001 vs NOD diseased control; § P <0.05, §§ P <0.01, §§§ P <0.001 vs placebo.

Abbreviation: NOD, NOD.B10.H2^b.

Figure 3 Representative periodic acid Schiff stained conjunctival goblet cells (100x magnification) at day 60.

Abbreviation: NOD, NOD.B10.H2^b.

Figure 4 Total number of goblet cells in the conjunctiva at day 60.

Notes: †† P <0.01 vs NOD diseased control; §§ P <0.01 vs placebo.

Abbreviations: NOD, NOD.B10.H2^b; SD, standard deviation.