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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.
AuthorsH K Soong, N F Martin, M D Wagoner, E Alfonso, S H Mandelbaum, P R Laibson, R E Smith, I Udell
JournalOphthalmology (Ophthalmology) Vol. 95 Issue 10 Pg. 1442-6 (Oct 1988) ISSN: 0161-6420 [Print] United States
PMID3067180 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References
  • Tretinoin
Topics
  • Administration, Topical
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Conjunctiva (pathology)
  • Conjunctival Diseases (drug therapy, pathology)
  • Double-Blind Method
  • Epithelium (pathology)
  • Female
  • Follow-Up Studies
  • Humans
  • Keratoconjunctivitis (drug therapy)
  • Keratoconjunctivitis Sicca (drug therapy, pathology)
  • Male
  • Metaplasia (drug therapy)
  • Middle Aged
  • Multicenter Studies as Topic
  • Prospective Studies
  • Random Allocation
  • Tretinoin (administration & dosage, adverse effects, therapeutic use)

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