title: Efficacy and safety of lodoxamide 0.1% vs cromolyn sodium 4% in patients with vernal keratoconjunctivitis.
abstract: A multicenter, double-masked, parallel-group clinical study compared the efficacy and safety of lodoxamide 0.1% ophthalmic solution and cromolyn sodium 4% ophthalmic solution in 120 patients with vernal keratoconjunctivitis. On various follow-up visits, the clinical efficacy of lodoxamide 0.1% was statistically superior to cromolyn sodium 4% in alleviating four of the primary symptoms (itching, tearing, foreign-body sensation, and discomfort) and five of the primary signs (Trantas' dots, palpebral conjunctival changes, bulbar conjunctival hyperemia, erythema/swelling of the eyelids and periorbital tissues, and epithelial disease). At no time during the study was cromolyn sodium 4% statistically superior to lodoxamide 0.1% in demonstrating improvements in clinical signs and symptoms of vernal keratoconjunctivitis. The physician's clinical judgment of patients' response to treatment showed lodoxamide 0.1% effected a greater and earlier improvement than cromolyn sodium 4%. Both drugs were safe for topical ophthalmic use when used four times daily for up to 28 days.
authors.affiliation: Department of Ophthalmology, Tulane University Medical Center, New Orleans, Louisiana 70112.
authors.forename: D R
authors.initials: DR
authors.lastname: Caldwell
authors.forename: P
authors.initials: P
authors.lastname: Verin
authors.forename: R
authors.initials: R
authors.lastname: Hartwich-Young
authors.forename: S M
authors.initials: SM
authors.lastname: Meyer
authors.forename: M M
authors.initials: MM
authors.lastname: Drake
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D003233:Conjunctivitis, Allergic / Q000188:drug therapy*; D004205:Cromolyn Sodium / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004361:Drug Tolerance; D005128:Eye Diseases / Q000139:chemically induced; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010072:Oxamic Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D004205:Cromolyn Sodium; D010072:Oxamic Acid; C021702:lodoxamide ethyl