The impact of topical cyclosporine A emulsion 0.05% on the outcomes of patients with keratoconjunctivitis sicca

Curr Med Res Opin. 2005 Jul;21(7):1057-63. doi: 10.1185/030079905X50615.


Objective: To assess patients' experiences with topical cyclosporine A (tCSA) 0.05% ophthalmic emulsion (Restasis) to treat keratoconjunctivitis sicca (KCS) in a real-world setting.

Methods: A total of 4504 ophthalmologists, optometrists and primary care physicians from throughout the United States participated in the study. Individual physicians identified patients from their practice who were appropriate candidates for treatment with tCSA and provided them with free sample medication and study materials. Patients voluntarily enrolled in the program by following the instructions provided in the study materials. Data for this study were obtained from patient surveys that included questions related to patients' experiences using topical cyclosporine A 0.05% ophthalmic emulsion (tCSA). Using automated surveys at baseline, 30-days and 60-days post-medication initiation, patients rated symptom severity, symptom impact on daily activities, and use of artificial tears pre- and post-treatment with study medication. Participants also reported on the rapidity of symptom relief and satisfaction with tCSA.

Results: A total of 5884 patients completed the study. The vast majority (84%) was female; average age was 63 years. Patients who completed the study (n = 5884) achieved significant reductions (p < 0.001) of 30% in symptom severity and 31%-36% in activity impairments relative to baseline. A positive association (p < 0.001) was observed between number of years with dry eye and the average ratings for symptom severity and impact on everyday activities. Onset of relief was noted within 1 week by 32% of patients and within 3 weeks by 73%. More than 60% reported decreased use of artificial tears at both 30 days and 60 days post-treatment initiation.

Conclusions: Results suggest that in a real-world setting tCSA is an effective treatment for patients suffering from KCS. Onset of relief may be more rapid than in previously published reports.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Topical
  • Cyclosporine / administration & dosage
  • Cyclosporine / therapeutic use*
  • Emulsions / administration & dosage
  • Female
  • Humans
  • Keratoconjunctivitis Sicca / diagnosis
  • Keratoconjunctivitis Sicca / drug therapy*
  • Male
  • Middle Aged
  • Treatment Outcome


  • Emulsions
  • Cyclosporine