June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Evaluation of 0.05% Cyclosporine Ophthalmic Emulsion on Ocular Surface Staining and Visual Function in Subjects Who Experience Discomfort While Engaging in Electronic Visual Tasking
Author Affiliations & Notes
  • Karl Stonecipher
    Ophthalmology, University of North Carolina, Greensboro, North Carolina, United States
  • Gail Torkildsen
    Andover Eye, Andover, Massachusetts, United States
  • Eugene B McLaurin
    Total Eyecare, Memphis, Tennessee, United States
  • Linda Villanueva
    Allergan, Inc, Irvine, California, United States
  • George W Ousler
    Ora, Inc, Andover, Massachusetts, United States
  • David A Hollander
    Ora, Inc, Andover, Massachusetts, United States
  • Footnotes
    Commercial Relationships   Karl Stonecipher, Alcon (C), Alcon (R), Allergan (C), Allergan (R), Shire (C), Shire (R); Gail Torkildsen, Allergan, Inc (C), Shire, Inc (C); Eugene McLaurin, Allergan, Inc (C), Shire, Inc (C); Linda Villanueva, Allergan, Inc (E); George Ousler, Ora, Inc (E); David Hollander, Ora, Inc (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 2661. doi:
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      Karl Stonecipher, Gail Torkildsen, Eugene B McLaurin, Linda Villanueva, George W Ousler, David A Hollander; Evaluation of 0.05% Cyclosporine Ophthalmic Emulsion on Ocular Surface Staining and Visual Function in Subjects Who Experience Discomfort While Engaging in Electronic Visual Tasking. Invest. Ophthalmol. Vis. Sci. 2017;58(8):2661.

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

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Abstract

Purpose : To assess the effect of a 6-month course of cyclosporine 0.05% ophthalmic emulsion (Restasis®, Allergan, Inc.) on ocular surface staining, visual function, and other measures of dry eye (DE) in subjects who experience discomfort while engaging in electronic visual tasking.

Methods : In this multi-center, open-label, 5-visit study, DE patients administered Restasis® twice-daily for 6 months. Patients were included in the study if they were 18 to 55 years of age, had a history of DE, used electronic devices (computers, tablets, phones) on a daily basis, had a score of 2 or greater on the Ora Calibra™ Ocular Discomfort and 4-Symptom Questionnaire, an Ocular Surface Disease Index (OSDI) score >12, and presence of corneal staining at visit 1. Primary efficacy endpoints were ocular surface staining, and visual performance at 6 months.

Results : Fifty one subjects were enrolled in the study; 46 subjects completed the study and were considered per protocol. Forty-one subjects were female (82%); mean subject age was 46.3±8.30. At 6 months, statistically significant reductions in all regional fluorescein staining was observed; in particular, central corneal staining was reduced by -0.75±0.66 (p<0.0001). Subjects also reported statistically significant improvements in visual function as measured by the OSDI questions for blurred vision (p<0.0001), poor vision (p=0.0002), driving at night (p=0.016), working with a computer (p<0.0001), and watching television (p<0.0001). Among secondary endpoints, Schirmer’s scores for all subjects was increased by 4.0±7.13 mm (p=0.0004), with 32% of all subjects increasing by at least 5 mm, and 16% increasing by at least 10 mm.

Conclusions : Restasis® improves ocular surface staining and patient reported visual function in patients who engage in electronic visual tasks after 6 months of dosing.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

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