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

H K Soong; Neil F Martin; M D Wagoner; E Alfonso; S H Mandelbaum; P R Laibson; Ronald E Smith; I Udell

doi:10.1016/S0161-6420(88)33009-5

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

Journal article

Peer reviewed

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

H K Soong, Neil F Martin, M D Wagoner, E Alfonso, S H Mandelbaum, P R Laibson, Ronald E Smith and I Udell

Ophthalmology (Rochester, Minn.), Vol.95(10), pp.1442-1446

10/1988

DOI: 10.1016/S0161-6420(88)33009-5

PMID: 3067180

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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.

Prospective Studies

Follow-Up Studies

Humans

Middle Aged

Metaplasia - drug therapy

Male

Conjunctival Diseases - drug therapy

Conjunctiva - pathology

Multicenter Studies as Topic

Keratoconjunctivitis Sicca - drug therapy

Aged, 80 and over

Adult

Female

Conjunctival Diseases - pathology

Epithelium - pathology

Tretinoin - administration & dosage

Double-Blind Method

Random Allocation

Keratoconjunctivitis - drug therapy

Tretinoin - therapeutic use

Keratoconjunctivitis Sicca - pathology

Adolescent

Tretinoin - adverse effects

Aged

Administration, Topical

Details

Title: Subtitle: Topical retinoid therapy for squamous metaplasia of various ocular surface disorders. A multicenter, placebo-controlled double-masked study
Creators: H K Soong - Department of Ophthalmology, University of Michigan Medical Center, Ann Arbor
Neil F Martin
M D Wagoner
E Alfonso
S H Mandelbaum
P R Laibson
Ronald E Smith - University of Southern California
I Udell
Resource Type: Journal article
Publication Details: Ophthalmology (Rochester, Minn.), Vol.95(10), pp.1442-1446
Publisher: United States
DOI: 10.1016/S0161-6420(88)33009-5
PMID: 3067180
ISSN: 0161-6420
eISSN: 1549-4713
Language: English
Date published: 10/1988
Academic Unit: Ophthalmology and Visual Sciences
Record Identifier: 9983980391302771

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