May 2008
Volume 49, Issue 13
ARVO Annual Meeting Abstract  |   May 2008
Topical Cyclosporine 0.05% for the Prevention of Dry Eye Disease Progression
Author Affiliations & Notes
  • S. N. Rao
    Ophthalmology, Lakeside Eye Clinic, Chicago, Illinois
  • Footnotes
    Commercial Relationships  S.N. Rao, None.
  • Footnotes
    Support  Study Supported by unrestricted educational grant from Allergan, Inc
Investigative Ophthalmology & Visual Science May 2008, Vol.49, 100. doi:
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      S. N. Rao; Topical Cyclosporine 0.05% for the Prevention of Dry Eye Disease Progression. Invest. Ophthalmol. Vis. Sci. 2008;49(13):100. doi:

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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose: : To determine if twice-daily treatment with topical cyclosporine 0.05% vs. Endura slows or halts the progression of signs and symptoms in patients with dry eye disease.

Methods: : Single-center, 12-month evaluation of 74 patients with dry eye disease. Patients were randomized to twice-daily treatment with either cyclosporine 0.05% (Allergan, Irvine) or artificial tears (Refresh Endura, Allergan, Irvine). Study visits were at baseline and months 4, 8, and 12. Outcome measures included Schirmer’s, OSDI, tear break-up time (TBUT), staining, and goblet cell density. ITF guidelines were used to determine progression.

Results: : There were no statistically significant between-group differences at baseline in any measurement (P>.05). Two-thirds of patients in both treatments groups were categorized as ITF level 2 at baseline. Patients treated with cyclosporine were significantly less likely to have progression of disease than patients treated with tears (5.5% of cyclosporine patients compared with 31.8% of tears patients, P=.007). Patients treated with cyclosporine were also significantly more likely to have the progression of their dry eye disease halted or improved than patients treated with tears (94% with cyclosporine versus 68.2% with tears, P=.007). Tear-treated patients were significantly more likely to discontinue treatment than cyclosporine-treated patients (33% versus 12%, P=.028). At 12 months, cyclosporine-treated patients had a mean improvement in Schirmer’s scores of 24.1%, compared with a mean decrease of 2.4% in tear-treated patients (P<.001). Cyclosporine also improved TBUT to a statistically significantly greater extent than tears (33.7% improvement with cyclosporine and 7.4% worsening with tears). In addition, cyclosporine provided a significant increase in goblet cells (24.8% improvement with cyclosporine compared with 3.2% decrease with tears, P<.001).

Conclusions: : These findings suggest that topical cyclosporine 0.05%, in contrast to artificial tears, increases goblet cell density and halts disease progression in patients with dry eye.

Clinical Trial: : NCT00567983

Keywords: cyclosporine • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • cornea: tears/tear film/dry eye 

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