Self-reported compliance with topical cyclosporine emulsion 0.05% and onset of the effects of increased tear production as assessed through patient surveys

Clin Ther. 2006 Nov;28(11):1848-56. doi: 10.1016/j.clinthera.2006.11.016.


Background: Keratoconjunctivitis sicca is a common eye condition characterized by itchiness, redness, and dryness due to a lack of tear production or abnormalities in the tear film. Cyclosporine works to increase the production of natural tears, which contain nutrients and proteins not found in artificial tears.

Objective: The purpose of this report was to assess the association between self-reported compliance with topical cyclosporine 0.05% emulsion and the onset of effects of increased tear production in patients with dry eye.

Methods: Practicing physicians were asked to identify patients for whom treatment with cyclosporine was appropriate and who were willing to participate in the study. Patients who agreed to participate were given medication samples and study materials. The participants were asked to respond to automated survey questions before they used cyclosporine and 30 and 60 days after initiating cyclosporine. Participants were asked how frequently they used the medication, how rapidly their symptoms were relieved, and whether they intended to continue using cyclosporine.

Results: Of the 5367 patients initially enrolled in the study, 3145 (59%) patients completed the baseline and 60-day follow-up surveys. The mean age of the participants was 60 years; 2677 (85%) of them were women, and 468 (15%) were men. Compliance with cyclosporine therapy was reported as follows: 2477 (79%) participants said they used cyclosporine twice daily as prescribed by their physicians, 468 (15%) reported missing some doses of cyclosporine, and 189 (6%) reported missing -50% or > or = 50% of the doses. The effects of increased tear production were reported to occur significantly sooner in participants who complied with cyclosporine treatment as prescribed than in those who did not comply with treatment (P < 0.01). Among those who complied with treatment, 1822 (73%) participants reported experiencing the effects of increased tear production in < 5 weeks compared with 468 (70%) participants who did not comply with treatment. Overall, the mean rate of satisfaction with cyclosporine was 7.5 on a scale from 0 (not at all satisfied) to 10 (very satisfied). Participants who reported using cyclosporine twice daily as prescribed gave satisfaction with cyclosporine a mean rating of 7.7 compared with 7.3 given by those who missed some doses and 5.3 from those who missed approximately 50% or > or = 50% of the doses (P < 0.01). An intention to continue using cyclosporine was reported by 2611 (83%) participants.

Conclusion: The results of this study in participants using cyclosporine for dry eye in an actual-practice setting suggest an association between patient-reported compliance with medication and more rapid onset of the effects of increased tear production.

Publication types

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

MeSH terms

  • Adult
  • Aged
  • Cyclosporine / pharmacology*
  • Data Collection
  • Female
  • Follow-Up Studies
  • Humans
  • Immunosuppressive Agents / pharmacology*
  • Keratoconjunctivitis Sicca / drug therapy*
  • Male
  • Middle Aged
  • Ophthalmic Solutions
  • Patient Compliance* / statistics & numerical data
  • Recovery of Function / drug effects
  • Time Factors


  • Immunosuppressive Agents
  • Ophthalmic Solutions
  • Cyclosporine