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Topical retinoid therapy for squamous metaplasia of various ocular surface disorders. A multicenter, placebo-controlled double-masked study.

Abstract：

:In a prospective, double-masked clinical study, the authors evaluated the efficacy and safety of topically applied tretinoin ophthalmic ointment (0.01%) versus placebo in the treatment of squamous metaplasia associated with various ocular surface disorders involving dry eyes. Study parameters consisted of graded symptoms and signs, and serial impression cytologies. A total of 161 patients were enrolled in the study. Of these patients, 116 who had a minimum of 4 to 8 months of follow-up qualified for final statistical analysis. These patients were classified into two major groups: (1) keratoconjunctivitis sicca (KCS) and (2) conjunctival cicatricial diseases (Stevens-Johnson syndrome, inactive pemphigoid, radiation-induced dry eye, drug-induced pseudopemphigoid, and toxic epidermal necrolysis). An analysis of adjusted mean changes for KCS patients showed no statistically significant differences between active drug and placebo. A similar analysis of patients with conjunctival cicatricial diseases indicated a statistically significant (P less than 0.05) reversal of conjunctival keratinization in the temporal bulbar site after treatment with active drug, however, clinical symptoms and signs showed no significant improvement with active drug relative to placebo. Side effects were limited to blepharoconjunctivitis and were reversible upon tapering or stopping the drug.

journal_name

Ophthalmology

journal_title

Ophthalmology

authors

Soong HK,Martin NF,Wagoner MD,Alfonso E,Mandelbaum SH,Laibson PR,Smith RE,Udell I

doi

10.1016/s0161-6420(88)33009-5

subject

Has Abstract

pub_date

1988-10-01 00:00:00

pages

1442-6

issue

10

eissn

0161-6420

issn

1549-4713

pii

S0161-6420(88)33009-5

journal_volume

95

pub_type

临床试验,杂志文章,多中心研究,随机对照试验

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