Abstract
Purpose
We conducted a study to evaluate the change of tear secretion and symptoms in the patients with dry eye syndrome after using Restasis® (Cyclosporine 0.05% ophthalmic emulsion, Allergan Inc., U.S.A.).
Methods
We randomly selected 39 patients from newly or previously diagnosed dry eye syndrome patients and administered Restasis® to them. We checked their clinical parameters and symptoms over a period of 3 months. The clinical parameters evaluated were type I and type II Schirmer tests and tear break-up time, and the symptoms of dry eye syndrome were classified into pain, itching, foreign body sensation, blurred vision, and photophobia using a scoring scale for symptoms of 0 to 5. The results were analyzed with a Mann-Whitney test ( P-values <0.05 was considered statistically significant).
Results
For 26 of 39 patients (52 eyes) on whom all tests were carried out for 3 months, there was a significant improvement after 3 months in the type I Schirmer test, type II Schirmer test, and tear break-up time ( P=0.012, 0.009, 0.001, respectively). Only 14 patients completed the questionnaire for scoring of symptoms. After using Restasis®, foreign body sensation only improved ( P=0.010).
Conclusions
In our study, tear secretion was increased by Restasis®, and a greater increase in tear secretion was seen in patients with systemic disease than in patients without systemic disease. Additional patients need to be evaluated and longer-term studies need to be performed to confirm our results.
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![]() | Figure 1.Schirmer test and tear breakup time changes (Δ) from baseline measured at 1 month, 2 months, 3 months, respectively (n=52). |
![]() | Figure 2.Comparison of increase amount in Schirmer Test with or, without systemic disease (n : number of eyes). |
Table 1.
Characteristics of study group at screening
Total number of group | n=39 |
Average of age (years) | 45.67±14.19 |
Gender | Male:14 Female:25 |
History of ocular surgery | 6 |
Systemic disease* | 15 |
No. of patients using other artificial tear drops | 28 |
Table 2.
Schirmer test and tear breakup time during 3 months (n=52, Mann-Whitney test)
First visit | After 1 month | After 2 months | After 3 months | ||
---|---|---|---|---|---|
Schirmer Test 1 (mm) | Average | 10.00±7.23 | 10.35±5.44 | 10.44±6.12 | 12.67±7.11 |
P value | 0.531 | 0.776 | 0.012 | ||
Schirmer Test 2 (mm) | Average | 7.00±4.88 | 8.60±4.68 | 8.10±4.55 | 9.48±5.30 |
P value | 0.103 | 0.284 | 0.009 | ||
BUT* (sec) | Average | 6.30±2.31 | 6.75±2.12 | 6.83±1.98 | 7.29±1.95 |
P value | 0.227 | 0.055 | 0.001 |
Table 3.
Symptom score of dry eye syndrome during 3 months (number of patient participating in Questionnaire=14, Mann-Whitney test)
Symptom Score* | First visit | After 1 month | After 2 months | After 3 months | |
---|---|---|---|---|---|
Irritation | average | 3.07 | 3.14 | 2.57 | 2.57 |
P value | 0.739 | 0.121 | 0.107 | ||
Itching | average | 1.78 | 1.43 | 1.43 | 1.43 |
P value | 0.102 | 0.336 | 0.380 | ||
Foreign body sensation | average | 3.00 | 2.26 | 2.20 | 2.16 |
P value | 0.024 | 0.028 | 0.010 | ||
Blurred vision | average | 2.21 | 1.71 | 1.71 | 1.93 |
P value | 0.084 | 0.154 | 0.365 | ||
Photophobia | average | 2.79 | 2.43 | 3.14 | 2.86 |
P value | 0.129 | 0.059 | 0.796 |