title: A double-masked study to compare the efficacy and safety of topical cromolyn for the treatment of allergic conjunctivitis.
abstract: OBJECTIVE
  To compare the efficacy and safety of topical cromolyn between with and without preservative for the treatment of allergic conjunctivitis.
  
  
  METHODS
  A double-masked study was performed in patients with allergic conjunctivitis. Each cromolyn sodium 2% ophthalmic solution with or without 0.01% benzalkonium chloride (BAK) was randomized to apply on either eye. The efficacy and safety were evaluated every other week by a questionnaire about ocular itching, redness and foreign body sensation, and objective scores of conjunctival redness, chemosis, cornea erosion and discharge using slit-lamp biomicroscopy. An overall response was also rated by physician's impression.
  
  
  RESULTS
  A total of 37 subjects were enrolled in this study but only 33 completed the study. All of subjective questionnaire scores showed a significant improvement after treatment in both groups. Objective score of redness significantly decreased after treatment in either groups but not chemisos or discharge. After 4-week treatment, corneal erosion diminished significantly in the group without preservative but not in the group with 0.01% BAK. There was no significant difference between with and without 0.01% BAK groups in each subjective or objective score. No adverse effect related with medication was observed.
  
  
  CONCLUSIONS
  Cromolyn 2 % ophthalmic solution was effective and safe to treat allergic conjunctivitis. A short-term use of cromolyn 2 % ophthalmic solution with 0.01% BAK would not cause any significant toxicity in patients with allergic conjunctivitis. Preservative-free cromolyn may be beneficial to the compromised eyes or eyes required of long-term medication.
authors: Department of Ophthalmology, National Taiwan University Hospital, College of Medicine, National Taiwan University, 7 Chung-Shan South Road. Taipei, Taiwan.
authors: Yao-lin
authors: YL
authors: Liu
authors: Fung-Rong
authors: FR
authors: Hu
authors: I-Jong
authors: IJ
authors: Wang
authors: Wei-Li
authors: WL
authors: Chen
authors: Yu-Chih
authors: YC
authors: Hou
mesh_terms: D000328:Adult; D001548:Benzalkonium Compounds / Q000008:administration & dosage; D003233:Conjunctivitis, Allergic / Q000188:drug therapy*; D004205:Cromolyn Sodium / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D006801:Humans; D008407:Mast Cells / Q000187:drug effects*; D008875:Middle Aged
chemical_list: D001548:Benzalkonium Compounds; D004205:Cromolyn Sodium