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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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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%).
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).
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).
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.
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