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Abstract
Purpose
To evaluate and compare the efficacy and sensation of instillation between 0.05% cyclosporine nanoemulsion group and microemulsion group.
Methods
This is a double-blind, prospective randomized clinical trial. Patients had 2 weeks of wash-out period before the study. They were randomly assigned to either nanoemulsion group or microemulsion group and treated with each group's cyclosporine eye drop. Artificial eye drop and topical steroid were used together according to severity of dryness of cornea. We checked every patient's Break-up time (BUT), Schirmer test, Staining Score and Ocular surface disease index (OSDI) on baseline, 1 month and 3 months after. Patients also self-checked frequency of use of artificial eye drop and topical steroid. Sensation of instillation was also checked.
Results
Both nanoemulsion eyedrop and microemulsion eyedrop improved BUT, Schirmer test, Staining Score and OSDI throughout 12 weeks. The nanoemulsion type reduced OSDI significantly compared to the microemulsion type. The mean frequency of use of artificial tear and topical steroid was similar in both groups. Foreign body sense score was higher in microemulsion group.
References
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Figure 1.
Comparison of OSDI between Nanoemulsion and Microemulsion group. Values are presented as mean ± standard deviation unless otherwise indicated. OSDI = ocular surface disease index; RM ANOVA = repeated-measured analysis of variance.
Figure 2.
Comparison of sensation of instillation between nanoemulsion and microemulsion group. Values are presented as mean ± standard deviation unless otherwise indicated. There was no statistically significant difference between 2 gruops by Independent t-test. Mo = months.
Table 1.
Demographics & baseline data of nanoemulsion and microemulsion group
| Nanoemulsion group | Microemulsion group | p-value | |
|---|---|---|---|
| Patients | 25 | 25 | |
| Sjögren's syndrome | 2:23 | 3:22 | 0.760* |
| Gender (male:female) | 1:24 | 8:17 | 0.092* |
| Age (years) | 57.84 ± 15.79 | 58.96 ± 13.58 | 0.554† |
| Baseline | |||
| BUT | 2.56 ± 1.19 | 2.72 ± 0.98 | 0.607† |
| Schirmer | 4.76 ± 3.62 | 4.80 ± 2.58 | 0.964† |
| Staining score | 2.24 ± 0.66 | 2.24 ± 0.60 | 1.000† |
| OSDI | 53.62 ± 20.02 | 42.79 ± 19.59 | 0.059† |
Table 2.
Comparison of result of RM-ANOVA test in BUT, Shirmer, Staining Score, OSDI between nanoemulsion and microemulsion group
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