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Peter S. Roland, MD; Debbie Anderson Eaton, MD; Robert D. Gross, MD, MBA; G. Michael Wall, PhD; Peter J. Conroy, PhD, JD; Rekha Garadi, PhD; Laura LaFontaine, MBA; Susan Potts, MS; Gail Hogg, BS

Arch Otolaryngol Head Neck Surg. 2004;130:1175-1177.

Objective  To evaluate the efficacy of 2 ceruminolytic products, Cerumenex Eardrops (Purdue Frederick Company, Norwalk, Conn) and Murine Ear Drops (Abbott Laboratories, Abbott Park, Ill), in subjects with partial or complete occlusion of the ear canal due to cerumen.

Design  Randomized, subject- and observer-blind, placebo-controlled, clinical trial.

Setting  Corporate research clinic.

Participants  From among 230 volunteers screened, 74 subjects (age, 22-66 [mean, 45] years) were enrolled in the study. Participants had baseline occlusion levels of mild (n = 10), moderate (n = 26), or complete (n = 38) impairment of tympanic membrane visualization.

Interventions  Subjects were randomly assigned to 1 of 3 treatments: Cerumenex (10% triethanolamine polypeptide oleate-condensate), Murine (6.5% carbamide peroxide), and a placebo, BSS Sterile Irrigating Solution (Alcon Laboratories Inc, Ft Worth, Tex). The test medication was instilled into 1 occluded ear for up to two 15-minute applications. Following the treatment, the subject's ear was irrigated with 50 mL of lukewarm water delivered at low pressure via a WaterPik irrigator equipped with a Grossan irrigator tip.

Main Outcome Measure  The degree of occlusion, measured against a previously established 4-point scale, was assessed and recorded at baseline and after each instillation and irrigation procedure.

Results  Neither Cerumenex nor Murine was superior to saline placebo. By the end of treatment, 29.2%, 15.4%, and 41.7% of subjects treated with Cerumenex, Murine, and placebo, respectively, experienced resolution of cerumen occlusion. These values were not statistically significantly different from one another.

Conclusion  The currently marketed ceruminolytic products, Cerumenex and Murine, are no more effective than a saline placebo in removing earwax.

From the Departments of Otolaryngology–Head and Neck Surgery (Drs Roland and Eaton) and Ophthalmology (Dr Gross), University of Texas Southwestern Medical Center, Dallas; and Alcon Research, Ltd, Fort Worth, Tex (Drs Wall, Conroy, and Garadi and Mss LaFontaine, Potts, and Hogg). Drs Roland and Gross are independent physicians, who serve as paid consultants for Alcon Research, Ltd, which sponsored this study.

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