May 2008
Volume 49, Issue 13
ARVO Annual Meeting Abstract  |   May 2008
Topical Loteprednol 0.5% Induction Therapy Improves Topical Cyclosporine Emulsion Tolerability in Chronic Dry Eye Disease
Author Affiliations & Notes
  • J. D. Sheppard, Jr.
    Dept of Ophthalmology, Eastern Virginia Medical Sch, Norfolk, Virginia
  • E. D. Donnenfeld
    Dept of Ophthalmology, Ophthalmic Consultants of Long Island, Rockville Center, New York
  • Footnotes
    Commercial Relationships  J.D. Sheppard, Allergan, Bausch & Lomb, C; E.D. Donnenfeld, Allergan, Bausch & Lomb, C.
  • Footnotes
    Support  Bausch & Lomb, Virginia Eye Foundation
Investigative Ophthalmology & Visual Science May 2008, Vol.49, 99. doi:
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      J. D. Sheppard, Jr., E. D. Donnenfeld; Topical Loteprednol 0.5% Induction Therapy Improves Topical Cyclosporine Emulsion Tolerability in Chronic Dry Eye Disease. Invest. Ophthalmol. Vis. Sci. 2008;49(13):99. doi:

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

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Purpose: : This prospective, randomized, placebo controlled, multi-center comparative trial evaluated the effects of loteprednol etabonate 0.5% suspension (LE) treatment prior to initiation of topical cyclosporine (CS) emulsion for patients with mild to moderate chronic dry eye disease (CDED).

Methods: : 118 patients aged 27-80 years, were enrolled, 61 in the LE treatment group and 57 in the artificial tears (AT) control group, including 93 females and 25 males. Patients received either LE or AT for two weeks QID, then initiated CS therapy BID accompanied by AT or LE BID for an additional 6 weeks for a total of 8 weeks under observation. Evaluation parameters included visual acuity, Ocular Surface Disease Index (OSDI), global self assessment, fluorescein and lissamine green staining, slit lamp examination, Schirmer's tear test, and IOP. Data was analyzed by ANOVA or student's T test.

Results: : LE pretreatment significantly reduced CS stinging (p<0.05). Both groups showed significantly improved OSDI scores at 14, 30 and 60 days. LE showed significantly more OSDI improvement than AT. Both pretreatment strategies improved global self assessment scores, Schirmers, fluorescein staining, lissamine staining, and artificial tear use. LE showed superior improvement in Schirmers, fluorescein staining and lissamine staining. IOP did not increase in either group.

Conclusions: : LE induction therapy 2 weeks prior to the institution of long term CS treatment for CDED improves subjective and objective clinical parameters compared to AT alone, thereby accelerating clinical improvement. LE also reduces the stinging side effect of CS drops. Stinging is the most common cause of CS therapy failure. Because 17% of CS patients experience significant stinging, LE induction therapy should be considered for patients with mild and moderate CDED, particularly when compliance may be an issue. LE induction could increase the overall number of patients who can benefit from long term CS maintenance therapy.

Clinical Trial: : NCT00407043

Keywords: clinical (human) or epidemiologic studies: outcomes/complications • cyclosporine • quality of life 

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