title: Double-blind trial of pentigetide ophthalmic solution, 0.5%, compared with cromolyn sodium, 4%, ophthalmic solution for allergic conjunctivitis.
abstract: Fifty patients (25 per group) with the signs and symptoms of allergic conjunctivitis confirmed by positive skin test enrolled in this randomized, double-blind, parallel group, 2-week comparison of pentigetide, 0.5%, ophthalmic solution (Pentyde) and cromolyn sodium, 4%, USP ophthalmic solution (Opticrom). The physician and the patient rated the patient's overall ocular condition on days 3, 8, and 15. On day 15 both the physician and the patients rated the pentigetide group as significantly (Chi-square, P less than .05) more improved than the cromolyn sodium group. The physician rated independently conjunctival symptoms and ocular signs at days 1, 3, 8, and 15. Improvement in signs and symptoms favored pentigetide in the majority of comparisons to cromolyn sodium (14 of 18). The pentigetide group showed significantly (ANOVA, P less than .05) greater improvement in hyperemia, edema, lacrimation, and blurred vision/photophobia. Patients completed daily diaries for seven symptoms. At the end of the study, comparisons to baseline between groups favored the pentigetide group for six of the seven symptoms; for itching, improvement favored significantly (ANOVA, P less than .05) the pentigetide group. The mean severity of all symptoms decreased by 64% in the pentigetide group as compared with a decrease of 46% in the cromolyn sodium group. Adverse experiences were minor and comparable in both groups. No clinically abnormal changes were noted for visual acuity, intraocular pressure, or common laboratory tests. This double-blind, active-controlled trial demonstrates that pentigetide, 0.5%, ophthalmic solution is safe and effective in the treatment of allergic conjunctivitis.
authors.affiliation: Immunetech Pharmaceuticals, San Diego, CA 92121.
authors.forename: J G
authors.initials: JG
authors.lastname: Kalpaxis
authors.forename: T O
authors.initials: TO
authors.lastname: Thayer
mesh_terms: D000293:Adolescent; D000328:Adult; D000595:Amino Acid Sequence; D003233:Conjunctivitis, Allergic / Q000188:drug therapy*; D004205:Cromolyn Sodium / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007073:Immunoglobulin E / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D008969:Molecular Sequence Data; D009842:Oligopeptides / Q000009:adverse effects / Q000627:therapeutic use*; D010446:Peptide Fragments / Q000627:therapeutic use*
chemical_list: D009842:Oligopeptides; D010446:Peptide Fragments; D007073:Immunoglobulin E; D004205:Cromolyn Sodium; C040297:pentigide