The Effect of Topical Cyclosporine 0.05% on Tear Osmolarity for Dry Eye Syndrome

Hyunseung Kang; San Seong; Chul Myong Choe; Se Kyung Kim; Tae Hoon Choi

doi:10.3341/jkos.2015.56.2.174

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Kang, Seong, Choe, Kim, and Choi: The Effect of Topical Cyclosporine 0.05% on Tear Osmolarity for Dry Eye Syndrome

Original Article

J Korean Ophthalmol Soc 2015;56(2):174-179.

Published online: 6 September 2015

DOI: https://doi.org/10.3341/jkos.2015.56.2.174

The Effect of Topical Cyclosporine 0.05% on Tear Osmolarity for Dry Eye Syndrome

Hyunseung Kang, MD, San Seong, MD, Chul Myong Choe, MD, Se Kyung Kim, MD, Tae Hoon Choi, MD, PhD

Nune Eye Hospital, Seoul, Korea

Address reprint requests to Tae Hoon Choi, MD, PhD, Nune Eye Hospital, #404 Seolleung-ro, Gangnam-gu, Seoul 135-841, Korea, Tel: 82-2-2086-7770, Fax: 82-2-2086-7779 E-mail: thchoi@hanmail.net

Received 16 May 20142 October 2014 Accepted 28 January 2015

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Purpose

To evaluate the effect of topical cyclosporine 0.05% (Restasis; Allergan, Irving, CA, USA) on tear osmolarity in patients with dry eye disease.

Methods

The present study was a single-center, randomized, prospective, and longitudinal trial. Patients who had been using artificial tears to treat dry eye disease were prescribed cyclosporine 0.05% and evaluated using tear osmolarity, tear break-up time, ocular surface staining score, Schirmer test, and the Ocular Surface Disease Index for symptomatic improvement. Clinical measurements of commonly used objective tests were performed at baseline and after 1, 3, and 6 months.

Results

At the end of the study, patients demonstrated statistically significant improvement in tear break-up time (6.26 ± 1.26 sec at 3 months vs. 4.41 ± 1.63 sec at baseline, p = 0.022) and OSDI (34.98 ± 20.19 at 3 months vs. 45.02 ± 22.38 at baseline, p = 0.032) only at 3 months. Other measures such as Schirmer test, ocular surface grade, and tear osmolarity also showed improvement. However, the differences were not significant.

Conclusions

Over a 6-month period, topical cyclosporine 0.05% showed beneficial effects on symptoms and other commonly used signs of dry eye disease for 3 months; however, the tear osmolarity values were not significantly improved.

Keywords: Cyclosporine, Dry eye syndrome, Restasis, Tear osmolarity

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Figure 1.

Tear breakup time (TBUT). Patients were treated with cyclosporine 0.05% for 6 months. TBUT was measured with fluorescein dye at indicated study visits. ^* p ≤ 0.05 compared with baseline (p = 0.305, ^* p = 0.022, p = 0.197 at 1, 3, and 6 months, respectively).

Figure 2.

Schirmer test scores. Patients were treated with cy-closporine 0.05% for 6 months. Schirmer I test was performed without anesthesia at the indicated study visits.

Figure 3.

Ocular surface disease index (OSDI) scores. Patients were treated with cyclosporine 0.05% for 6 months. Dry eye signs and symptoms were assessed by the self-reported OSDI questionnaire at the indicated study visits. According to the OSDI classification, the scores indicate mild to moderate disease severity. ^* p < 0.05 compared with baseline (p = 0.242, ^* p = 0.032, p = 0.814 at 1, 3, and 6 months, respectively).

Figure 4.

Ocular surface staining scores. Patients were treated with cyclosporine 0.05% for 6 months. Ocularsurface damage was assessed at the indicated times by the Oxford method. The change from baseline was calculated by subtracting the baseline score from the 1, 3, or 6 month scores. The changes from baseline were paired comparisons.

Figure 5.

Tear osmolarity. Patients were treated with cyclo-sporine 0.05% for 6 months. Tear osmolarity was assessed by TearLab™ at indicated study visits. Tear osmolarity was measured prior to any other objective tests and was performed only in the left eye and only once.

Table 1.

Demographics and follow-up data of study patients

Patients (n)
Enrolled in study	86
Followed up
1 month	36
3 months	26
6 months	18^∗
Age (years)	49.7 ± 12.9
Range	22-85
Age ≥ 50	44 (51.2%)
Sex^† (n, %)
M:F	3:15 (16.7:83.3)
History of previous ocular surgery (n, %)	1 (1.2)

Values are presented as mean ± SD unless otherwise indicated.

^∗ Three patients discontinued the study because of discomfort upon instillation, the rest was lost to follow-up

^† For patients who completed 6-month study.

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