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Abstract
Purpose
To evaluate the therapeutic effect of topical vitamin A-containing lubricant in dry eye patients.
Methods
Three hundred eyes of 150 patients with dry eye (Schirmer I test≤10 mm, BUT≤10 seconds) were divided into three groups. Preservative-containing artificial tears, preservative-free artificial tears, and vitamin A-containing lubricant were administrated to Groups 1, 2, and 3, respectively (N=50). We evaluated and checked symptom scores, tear film breakup time (tBUT), Schirmer I test results, corneal fluorescein stain scores, and impression cytology immediately and at 1, 2, and 3 months after treatment.
Results
Mean tBUT and goblet cell density significantly increased from 5.06±1.25 to 6.76±1.21 sec and from 125.62±61.52 to 192.86±69.38 cell/mm2, respectively, after 2 months in group 3 ( P<0.05). Impression cytology grade significantly decreased from 2.14±0.38 to 1.67±0.41 after 2 months in group 3 ( P<0.05). The Schirmer I test score significantly increased from 9.12±4.15 to 12.83±0.96 mm, and the corneal stain score decreased from 2.13±0.95 to 1.18±0.68 after 3 months in group 3 ( P<0.05).
References
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Figure 1
. Change from the baseline in blurred vision symptom scale. O-HU=Lacure®; O-RFR=Refresh plus®; O-viva=Viva®; Mean value±standard error. Graded on a symptom scale from 0 to 4. Statistically significant decreases of blurred vision from baseline at all follow-up visits in group 3 are shown (* P<0.05 by Mann-Whitney U Test).
Figure 2
. Change from the baseline in tear breakup time. O-HU=Lacure®; O-RFR=Refresh plus®; O-viva Viva®; Mean value±standard error. The increase from the baseline in tear breakup time (sec) was statistically significant in group 3 at 2 months and 3 months. (* P<0.05 by paired-T-test).
Figure 3
. Change from baseline in Schirmer I test. O-HU: Lacure®; O-RFR: Refresh plus®; O-viva: Viva® Mean value± standard error. The increase from baseline in Schirmer test value (mm) was statistically significant in groups 3 at 3 months. (* P<0.05 by paired-T-test).
Figure 4
. Change from the baseline in impression cytology grade. O-HU=Lacure®; O-RFR=Refresh plus®; O-viva=Viva®; Mean value±standard error. The decrease from the baseline in impression cytology grade was statistically significant in group 3 at 2 months and 3 months. (* P<0.05 by Mann- Whitney U Test).
Figure 5
. Example of impression cytology after 3 months in each group. Group 1=Lacure®; Group 2=Refresh plus®. Group 3= Viva®. There was no significant improvement in impression cytology after 3 months in group 1 (A=Stage 3-initial; B=Stage 3-after 3 months) and group 2 (C=Stage 3-initial; D=Stage 3-after 3 months). But improvement of impression cytology was shown after 3 months in group 3 (E=Stage 3-initial, F=Stage 2-after 3 months) (×100, PAS-hematoxylin stain). <Stage 0- Normal, Stage 1-early loss of goblet cells, Stage 2- total loss of goblet cells, Stage 3- early keratinization, Stage 4- moderate keratinization, Stage 5- advanced keratinization>
Figure 6
. Change from baseline in goblet cells density. O-HU: Lacure®, O-RFR: Refresh plus®, O-viva: Viva®; Mean value±standard error. The increase from baseline in goblet cells density (cell/mm2) was statistically significant in group 3 at 2 months and 3 months. (* P<0.05 by paired-T-test).
Figure 7
. Change from the baseline in corneal stain score. O-HU=Lacure®; O-RFR=Refresh plus®; O-viva=Viva®; Mean value±standard error. The decrease from baseline in corneal stain score was statistically significant in group 3 at 3 months. (* P<0.05 by Mann-Whitney U Test).
Table 1.
Initial characteristics of each group
Table 2.
Patient disposition during 3-month follow-up
| Group 1 | Group 2 | Group 3 | |
|---|---|---|---|
| Patients enrolled | 50 (100%) | 50 (100%) | 50 (100%) |
| Patients completed | 41 (82%) | 44 (88%) | 46 (92%) |
| Patients discontinued | 9 (18%) | 6 (12%) | 4 (8%) |
| Adverse events | 2 (4%) | 1 (2%) | 3 (6%) |
| Other reasons* | 7 (14%) | 5 (10%) | 1 (2%) |
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