March 2012
Volume 53, Issue 14
ARVO Annual Meeting Abstract  |   March 2012
Evaluating the Efficacy of Systane Ultra Post Discontinuation of Long-term Use of Restasis (cyclosporine ophthalmic emulsion 0.05%)
Author Affiliations & Notes
  • Roy S. Chuck
    Department of Ophthalmology, Albert Einstein College of Medicine, Bronx, New York
  • John Schachet
    Eyecare Consultants, Denver, Colorado
  • Footnotes
    Commercial Relationships  Roy S. Chuck, Alcon (C); John Schachet, Alcon (C)
  • Footnotes
    Support  Alcon Research Ltd.
Investigative Ophthalmology & Visual Science March 2012, Vol.53, 2354. doi:
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      Roy S. Chuck, John Schachet; Evaluating the Efficacy of Systane Ultra Post Discontinuation of Long-term Use of Restasis (cyclosporine ophthalmic emulsion 0.05%). Invest. Ophthalmol. Vis. Sci. 2012;53(14):2354.

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

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Purpose: : To evaluate the efficacy of a lubricant eye drop, polyethylene glycol/propylene glycol (PEG/PG Systane®) given as an immediate treatment replacement in subjects that discontinued after at least 6 months use of Restasis® (cyclosporine ophthalmic emulsion 0.5%).

Methods: : This was a single (patient) masked study design in 48 dry eye subjects at 7 sites currently using Restasis® twice daily for a minimum of 6 months (including concomitant artificial tear therapy) along with NaFl corneal staining total score of ≥ 3 (5 corneal sectors, 0-3/sector, maximum score of 15 - NEI staining scale) and BCVA of 0.6 LogMAR or better in each eye based on ETDRS chart. NaFl corneal staining, ocular signs, TFBUT, conjunctival staining, Schirmers I tear test, OSDI, IDEEL and WPAI:SHP questionnaires were collected at 2 weeks, 1, 2 and 4 months of treatment. Subjects were instructed to use the replacement treatment 1-2 drops in each eye 4 times daily for 4 months. Evaluations of each of the above was taken at 2 weeks, 1, 2 and 4 months and compared to baseline (Day 0).

Results: : Mean (+/- SD) corneal staining was statistically significantly reduced over the treatment period 6.4 (2.7), 5.21 (3.0), 4.77 (3.1) and 4.65 (3.2) at 2 weeks, 1, 2 and 4 months respectively (p < 0.001 at each post-baseline time point). There was also a significant reduction in total conjunctival staining at 2 weeks, 2 months and 4 month (p≤ 0.001). Maintenance of ocular signs, TFBUT, Schirmers I, OSDI and WPAI:SHP were observed over the 4 month treatment period. There was also a significant improvement observed with the IDEEL-treatment satisfaction score at 4 months (p=0.028).

Conclusions: : Dry eye patients who were previously symptomatically controlled by Restasis® and switched to Systane® Ultra showed improvement in corneal and conjunctival staining as well as the treatment satisfaction portion of the IDEEL questionnaire. These results may indicate an alternative to long-term Restasis® use in dry eye patients.

Clinical Trial: : NCT01198782

Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • cornea: tears/tear film/dry eye • cyclosporine 

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