The IMPACT study: a prospective evaluation of the effects of cyclosporine ophthalmic emulsion 0.05% on ocular surface staining and visual performance in patients with dry eye

Karl G Stonecipher,^1,2 Gail L Torkildsen,³ George W Ousler III,⁴ Scot Morris,⁵ Linda Villanueva,⁶ David A Hollander<sup>6

1</sup>Department of Ophthalmology, University of North Carolina, Chapel Hill, ²TLC Laser Eye Centers, Greensboro, NC, ³Andover Eye Associates, ⁴Ora, Inc., Andover, MA, ⁵Eye Consultants of Colorado, Conifer, CO, ⁶Allergan plc, Irvine, CA, USA

Objective: The aim of this study was to evaluate the effects of cyclosporine ophthalmic emulsion 0.05% on ocular surface staining and visual performance in patients with dry eye.
Methods: This was a single-center, 6-month, open-label, Phase IV study. Patients with bilateral dry eye disease and a symptom score of ≥2 on the Ocular Discomfort and 4-Symptom Questionnaire, an Ocular Surface Disease Index score of >12, at least one eye with Schirmer's score <10 mm/5 minutes, and central corneal staining graded as ≥2 on the Ora Calibra™ Corneal and Conjunctival Staining Scale were enrolled. Cyclosporine ophthalmic emulsion 0.05% (Restasis^®) was instilled twice daily in each eye. The primary efficacy endpoints were ocular surface staining and visual function at 6 months. Secondary outcome measures included Schirmer's test, tear film breakup time, symptoms, and adverse events.
Results: A total of 40 patients with the mean age of 59.4 years (range, 40–78 years) were enrolled; 35 (87.5%) were female and 37 (92.5%) completed the study. At 6 months, inferior corneal, central corneal, total corneal, and total ocular surface fluorescein staining were significantly improved from baseline in both eyes (P<0.001). Patient responses on the Ocular Surface Disease Index showed significant improvement in blurred vision and visual function related to reading, driving at night, working with a computer or bank machine, and watching television (P≤0.041). At 6 months, 35.1% of patients achieved ≥5 mm improvement and 18.9% achieved ≥10 mm improvement in the average eye Schirmer score. Mean tear film breakup time improved by >50% in both eyes (P<0.001). Patients reported significant improvement in ocular discomfort and dry eye symptoms (P<0.001). No patients discontinued treatment because of stinging or any other ocular adverse event.
Conclusion: Dry eye patients with difficulties with day-to-day visual function demonstrated improvement in both signs and symptoms of dry eye and reported improved visual function after 6 months of treatment with cyclosporine ophthalmic emulsion 0.05%.

Keywords: corneal staining, dry eye disease, Ocular Surface Disease Index, ocular surface staining, visual function, clinical trial

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