title: Corneal ulcer and adverse reaction rates in premarket contact lens studies.
abstract: We analyzed clinical data on 22,739 contact lens wearers who were studied and whose lenses were approved under 48 manufacturer-sponsored studies for the Food and Drug Administration between 1980 and 1988. The incidence of corneal ulcers was low in the cosmetic (nontherapeutic) daily-wear soft and rigid gas-permeable lens wearers (1/1,923 and 1/1,471 patient-years, respectively). Corneal ulcers and severe adverse reactions occurred two to four times more frequently in extended-wear cosmetic soft and rigid gas-permeable lens wearers than in cosmetic daily-wear lens wearers. Aphakic extended-wear soft lens users were nine times more likely to develop a corneal ulcer when compared to the soft daily-wear cosmetic group. Corneal abrasions and keratitis accounted for 81 of 159 severe adverse reactions, whereas corneal ulcers accounted for 28 of 159 adverse reactions. The data indicate that overnight extended wear of contact lenses is associated with a greater risk of serious, sight-threatening complications than daily wear.
authors.affiliation: Food and Drug Administration, Washington, D.C.
authors.forename: S
authors.initials: S
authors.lastname: MacRae
authors.forename: C
authors.initials: C
authors.lastname: Herman
authors.forename: R D
authors.initials: RD
authors.lastname: Stulting
authors.forename: R
authors.initials: R
authors.lastname: Lippman
authors.forename: D
authors.initials: D
authors.lastname: Whipple
authors.forename: E
authors.initials: E
authors.lastname: Cohen
authors.forename: D
authors.initials: D
authors.lastname: Egan
authors.forename: C P
authors.initials: CP
authors.lastname: Wilkinson
authors.forename: C
authors.initials: C
authors.lastname: Scott
authors.forename: R
authors.initials: R
authors.lastname: Smith
mesh_terms: D001035:Aphakia / Q000150:complications; D003262:Contact Lenses, Extended-Wear; D003263:Contact Lenses, Hydrophilic / Q000009:adverse effects*; D003316:Corneal Diseases / Q000209:etiology; D003320:Corneal Ulcer / Q000209:etiology*; D006801:Humans; D015994:Incidence; D007634:Keratitis / Q000209:etiology; D014481:United States; D014486:United States Food and Drug Administration