To compare autonomic effects of botulinum toxin (BTX), we randomized patients with cervical dystonia to receive either BTX-A or BTX-B in a double-blind manner. Efficacy and physiologic questionnaire measures of autonomic function were assessed at baseline and 2 weeks after injection. Patients treated with BTX-B had less saliva production (p < 0.01) and greater severity of constipation (p = 0.037) than those treated with BTX-A, but did not differ in other tests of autonomic functions.
A study was conducted to determine the safety and efficacy of topically applied ciprofloxacin ophthalmic solution in a pediatric population experiencing acute bacterial conjunctivitis. Topically applied ciprofloxacin (3 mg/mL) is known to be a safe and effective treatment for adults suffering from bacterial conjunctivitis; however, the safety and effectiveness of this broad-spectrum fluoroquinolone in pediatric patients is not well established. Ciprofloxacin was evaluated in a double-blind, randomized, controlled study of 257 patients ranging from 0 (i.e., less than 1 year) to 12 years of age from 33 geographically diverse medical centers. The children received either 0.3% ciprofloxacin ophthalmic solution (Ciloxan, Alcon Laboratories, Fort Worth, TX) or tobramycin ophthalmic solution (Tobrex, Alcon Laboratories, Fort Worth, TX). Both test medications were administered topically every 2 hours on days 1 and 2 followed by every 4 hours on days 3 through 7. Eyes were cultured prior to enrollment and again on day 7. Treatment efficacy as determined by microbiological culture data and physicians' judgment of overall resolution was similar for the ciprofloxacin and tobramycin groups. Microbiological eradication was observed in 90.1% of the ciprofloxacin group and 84.3% of the tobramycin group (P = 0.29). Physicians judged 87.0% of the ciprofloxacin patients and 89.9% of the tobramycin patients clinically cured on day 7 (P > 0.5). There were no serious adverse medical events attributable to either treatment. This study showed that topically applied ciprofloxacin ophthalmic solution is safe and effective in a pediatric population experiencing acute bacterial conjunctivitis.
Olopatadine hydrochloride ophthalmic solution 0.2% (Pataday, Alcon) is a new formulation of olopatadine hydrochloride ophthalmic solution, the first topical ocular antiallergic agent indicated for once-daily dosing. The aim of this study was to evaluate the safety, efficacy, onset, and duration of action of olopatadine 0.2% in the treatment of allergic conjunctivitis. Using the conjunctival allergen challenge, this double-masked, randomized by eye, parallel-group study included four visits over a 5-week period. Subjects were screened for eligibility (visit 1) and their ocular allergic responses were confirmed at visit 2. The efficacy of olopatadine in reducing the signs and symptoms of allergic conjunctivitis was evaluated at onset of action (visit 4) and 16 hours (visit 3) after masked medication instillation. The primary efficacy parameter was ocular itching. Safety parameters were also evaluated. Ninety subjects were evaluated. Olopatadine 0.2% was significantly (p < 0.001) more effective than placebo in the treatment of ocular itching at all time points at both the onset of action and the 16-hour allergen challenges. Olopatadine 0.2% was significantly (p < 0.03) more effective than placebo in the reduction of conjunctival redness, chemosis, and eyelid swelling at all time points (with the exception of conjunctival redness, which was significantly reduced at five of six time points). There were no serious adverse events and no treatment-related adverse events. Once-daily dosing with olopatadine 0.2% reduced the signs and symptoms of allergic conjunctivitis with a rapid and prolonged duration of action. Safety analyses indicated that olopatadine 0.2% was safe and well tolerated in subjects with a history of allergic conjunctivitis.
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.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.