research in practice

Restasis: Once or Twice?

A new study reveals dosing the dry eye therapy once a day may be possible.

Mile Brujic, O.D., and Crystal Brimer, O.D.

The ideal approach to managing dry eye disease is one that utilizes the most convenient and economical means possible to effectively alleviate a patient's symptoms. In this regard, researchers have taken a step forward: Recently, a study revealed that topical cyclosporine A 0.05% (tCSA) (Restasis, Allergan) used q.d. may be just as effective as b.i.d. dosing in patients who have already responded well to one-year of Restasis therapy.¹

The supporting research

The study explored the effect of decreasing the dosage of Restasis to q.d. dosing. All 100 subjects in the study had been previously diagnosed with mild-to-severe dry eye disease and experienced a cessation of symptoms during the past year while using Restasis b.i.d.

The patients were randomized into two groups: those who continued to receive Restasis b.i.d. and those whose dosage was reduced to q.d. This observer-masked, randomized study compared data within each group through time as well as between groups. The study's researchers classified patients by disease severity in order to assess whether results varied accordingly.

The study's researchers measured fluorescein tear break-up time (TBUT), corneal fluorescein staining scores, lissamine green staining scores, Schirmer tear test (anesthetized) results and the ocular surface disease index (OSDI) at baseline, three months and six months.

Results

When comparing mean data within the study group, the researchers noted no negative changes between baseline and six months in the q.d. group and actually saw improvement in TBUT values and conjunctival staining with lissamine green with no negative changes among the other dry eye variables in this group.

After three months, the q.d. group showed better TBUT values, OSDI values and less corneal staining than the b.i.d. group, while the other dry eye measures were equal. However, after six months, the researchers didn't see any statistically significant differences between the two groups, with the exception of the OSDI scores. Surprisingly, severe dry eye patients in the study group reported superior OSDI scores compared with these patients in the control group.

This study substantiates that after a year of successful symptom control with Restasis b.i.d., these patients are likely able to decrease their dosage to q.d. without detriment. Future studies will likely explore the long-term effects of the decreased dosage on clinical outcomes.

Another study

Eyecare practitioners have long utilized Restasis to control the inflammatory component associated with dry eye. One study documented improved outcome when dry eye patients used Restasis b.i.d. plus preservative-free artificial tears q.i.d., vs. the artificial tears alone, also used q.i.d.² Here, the study group using both Restasis and tears experienced improvement of each measure tested, such as TBUT values, and these values were significantly superior to those in the control group.

This study revealed that goblet cell density increased with Restasis use. Poor goblet cell density is linked to conjunctival inflammation and ocular surface disease. Increasing the goblet cell density leads to improved mucin production, which enhances tear film stability. The control group using only tears did not experience improvement in goblet cell density or in conjunctival inflammation.

What this means for patients

Restasis therapy has been a well-accepted treatment for dry eye signs and symptoms as a result of the numerous therapeutic benefits that it delivers to the ocular surface. Reducing a patient's Restasis dosing regimen after a year of b.i.d. dosing may enhance patient compliance and improve their therapeutic outcome. It also offers significant financial savings for the patient.

The real world application

With those patients whose dry eye is managed utilizing Restasis b.i.d., consider a q.d. dosing schedule after a year of successful remission of symptoms. Note that this approach might not be appropriate for all dry eye patients (14% of study participants reverted to b.i.d. dosing), and the study did not assess which patient factors would determine either success or failure with reduced dosing. Therefore, once you have decreased the dosage, monitor these patients with follow-up visits for the first one-to-three months.

Be aware that this is a non-FDA-approved therapeutic regimen, but that the decreased dosage is likely to sustain resolution of patients' dry eye symptoms. Such results provide us with the opportunity to improve patient care and offer a more convenient and less expensive dosing regimen of Restasis without sacrificing symptom control. OM

1. Su MY, et al. The effect of decreasing the dosage of cyclosporine A 0.05% on dry eye disease after 1 year of twice-daily therapy. Cornea 2011 Oct;30(10):1098-104.
2. Demiryay E, et al. Effects of topical cyclosporine a plus artificial tears versus artificial tears treatment on conjunctival goblet cell density in dysfunctional tear syndrome. Eye & Contact Lens. 2011 Sept; 37(5):312-5.