J Korean Ophthalmol Soc.  2015 Feb;56(2):174-179. 10.3341/jkos.2015.56.2.174.

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

• Kang H
• Seong S
• Choe CM
• Kim SK
• Choi TH

• KMID: 2215999
• DOI: http://doi.org/10.3341/jkos.2015.56.2.174

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.

Keyword

Cyclosporine; Dry eye syndrome; Restasis; Tear osmolarity

MeSH Terms

Cyclosporine*
Dry Eye Syndromes*
Eye Diseases
Humans
Ophthalmic Solutions
Osmolar Concentration*
Prospective Studies
Tears*
Cyclosporine
Ophthalmic Solutions

Figure

• 

  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.

Reference

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