Journal List > J Korean Ophthalmol Soc > v.49(10) > 1008098

Soo Byun, Jeon, and Chung: Clinical Effect of Cyclosporine 0.05% Eye Drops in Dry Eye Syndrome Patients



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.).


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).


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).


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

* bone marrow transplanted patient=8; Steven-Johnson syndrome=4; Systemic lupus erythematus=2; Sjögrene syndrome=1.

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

* Tear breakup time.

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

* Score 0: no symptom; score 5; the most severe symptom so far.

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