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Efficacy and safety of topical azelastine compared with topical mitomycin C in patients with allergic conjunctivitis.

Author(s): Sodhi PK, Pandey RM, Ratan SK

Affiliation(s): Department of Ophthalmology, Safdarjung Hospital, New Delhi, India. hardeep333@hotmail.com

Publication date & source: 2003-04, Cornea., 22(3):210-3.

Publication type: Clinical Trial; Evaluation Studies; Randomized Controlled Trial

PURPOSE: To compare the efficacy and safety of topical azelastine with topical mitomycin C (MMC) in patients with allergic conjunctivitis. METHODS: Sixty-three patients (29 male, 29 female; 34 in the age range of 6 to 65 years) with allergic conjunctivitis were enrolled in this study. The patients were randomly assigned to receive topical azelastine 0.02% (n = 31) or topical MMC (0.2 mg/10 mL) (n = 31) four times daily for 3 months. Follow-up examinations were done at 2 weeks to examine side effects of the medications and again at 4 weeks to assess the outcome of treatment. The eyes were examined for relief of symptoms, cure of signs, and the appearance of side effects with use of these drugs. RESULTS: The mean age of the patients in this study was 34.8 +/- 17.3 years. The age of patients in the MMC group was significantly higher than patients in the azelastine group (mean +/- SD, 25.2 +/- 13.5 years). More patients in the MMC group had relief of symptoms like redness [25 (80.7%) in the MMC group versus 19 (55.9%) in the azelastine group; p= 0.033], photophobia [11 (35.5%) in the MMC group versus six (17.7%) in the azelastine group; not significant], discharge [17 (54.8%) in the MMC group versus 11 (32.3%) in the azelastine group; not significant], and foreign body sensation [21 (67.7%) in the MMC group versus 16 (47.1%) in the azelastine group; not significant], while more patients in the azelastine group had relief of lacrimation [14 (41.2%) in the azelastine group versus 10 (32.3%) in the MMC group; not significant] and pain [12 (35.3%) in the azelastine group versus eight (25.8%) in the MMC group; not significant]. The MMC group also showed a greater decrease in follicles [31 (100.0%) in the MMC group versus six (17.7%) in the azelastine group; p= 0.0001] and papillae [29 (93.6%) in the MMC group versus four (11.8%) in the azelastine group; p= 0.0001]. Both drugs were found to be equally effective in relieving itching [18 (58.1%) in the MMC group versus 18 (52.9%) in the azelastine group; not significant]. In the MMC group, 27 (87.1%) patients had conjunctival hyperemia, 28 (90.3%) patients had episcleritis, and 29 (93.6%) patients had irritation. The use of topical azelastine did not cause any adverse event. CONCLUSIONS: Though this was a short-term study, we found topical MMC to be more effective than topical azelastine in the treatment of allergic conjunctivitis both in terms of relief of symptoms and resolution of signs. The use of topical MMC in low doses does not cause any significant adverse effect.

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