A double-masked study to compare the efficacy and safety of topical cromolyn for the treatment of allergic conjunctivitis
Journal
Journal of the Formosan Medical Association
Journal Volume
110
Journal Issue
11
Pages
690-694
Date Issued
2011
Author(s)
Abstract
Background/Purpose: 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. Conclusion: 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. ? 2011.
SDGs
Other Subjects
benzalkonium chloride; cromoglycate disodium; eye drops; adult; aged; allergic conjunctivitis; article; chemosis; clinical article; conjunctiva disease; conjunctiva redness; controlled study; cornea erosion; drug efficacy; drug safety; foreign body; hospital discharge; human; ocular pruritus; parallel design; questionnaire; randomized controlled trial; slit lamp; treatment outcome; treatment response; unspecified side effect; Adult; Benzalkonium Compounds; Conjunctivitis, Allergic; Cromolyn Sodium; Double-Blind Method; Humans; Mast Cells; Middle Aged
Type
journal article