Pilot trial of cyclosporine 1% ophthalmic ointment in the treatment of keratoconjunctivitis sicca.

Abstract:

:This trial was a randomized, double-masked, crossover study during which patients with keratoconjunctivitis sicca underwent 6 weeks of treatment with either cyclosporine 1% ophthalmic ointment or placebo followed by 6 weeks of the alternative treatment. Washout periods using only unpreserved artificial tears preceded both treatment cycles. Twenty-five patients completed the first treatment period, but only eight met entry criteria for period II. Cyclosporine ointment was associated with initial mild to moderate redness, itching, and burning that returned to baseline levels within 1-2 weeks. Rose Bengal results and results of four subjective (patient diary) efficacy parameters favored cyclosporine: foreign body sensation, overall symptoms, hours of symptom control per day, and overall effectiveness. No systemic adverse events or laboratory abnormalities occurred. We conclude that (a) the crossover design is inappropriate for studying this disease; (b) mild to moderate itching, redness, and burning occur initially with cyclosporine administration, although tolerance quickly develops; (c) cyclosporine appears to benefit the ocular surface in keratoconjunctivitis sicca; and (d) further trials in this syndrome are warranted.

journal_name

Cornea

journal_title

Cornea

authors

Laibovitz RA,Solch S,Andriano K,O'Connell M,Silverman MH

doi

10.1097/00003226-199307000-00007

subject

Has Abstract

pub_date

1993-07-01 00:00:00

pages

315-23

issue

4

eissn

0277-3740

issn

1536-4798

journal_volume

12

pub_type

临床试验,杂志文章,随机对照试验

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