A systematic review of the effectiveness of ofloxaxin otic solution for the treatment of suppurative otitis media

The objectives of the study were to determine the effectiveness and incidence of adverse events of ofloxacin otic solution for suppurative otitis media compared with other treatments. All randomized controlled trials and nonrandomized comparative clinical trials published from 1966 to 2000 using ofloxacin otic solution as one of the interventions were reviewed and data were extracted and analyzed. Eleven clinical trials (9 randomized and 2 nonrandomized) enrolling 1,484 adults and children were finally included in the analysis. Five studies employed clear concealment procedure in the allocation of treatment whereas evaluation of outcome was at least single-blinded in 6 trials. The probability of overall cure rate was higher with 0.3% ofloxacin otic solution than with other topical or systemic antibiotics in 9 of the studies analyzed (OR = 2.67; 95% CI = 2.04, 3.50). Resolution of secondary outcome parameters evaluated at least 1 week after treatment was higher with 0.3% ofloxacin otic solution: resolution of otalgia (4 trials; OR = 2.41; 95% CI = 1.2, 4.82); resolution of otorrhea (11 trials; OR = 2.78; 95% CI = 2.12, 3.65), and bacterial eradication rate (6 trials; OR = 3.86; 95% CI = 2.54, 5.87). A subgroup analysis of 4 studies comparing ofloxacin otic solution with antibiotic- and steroid-containing otic solution showed a higher cure rate for ofloxacin otic solution (OR = 2.73; 95% CI = 1.52, 4.90). Another subgroup analysis on 3 studies comparing ofloxacin otic solution with oral systemic antibiotics showed higher resolution of otorrhea with ofloxacin otic solution (OR = 2.78; 95% CI = 2.12, 3.65). Of 4 studies with data on adverse events, the probability of adverse events was lower with ofloxacin otic solution than with other topical antibiotics (OR = 0.28; 95% CI = 0.19, 0.42). Subgroup analysis showed that 0.3% ofloxacin otic solution showed better results in terms of overall cure rate, resolution of otorrhea, otalgia, bacterial eradication rate and incidence of adverse events. Whether due to chronic suppurative otitis media (CSOM) or draining tympanostomy tube, the overall cure rate (CSOM OR = 4.86; with tympanostomy tube OR = 2.13) and resolution of otorrhea (CSOM OR = 4.42; with tympanostomy tube OR = 1.66) were likewise in favor of 0.3% ofloxacin otic solution. The studies included in this meta-analysis showed generally homogenous results in all clinical and laboratory outcomes analyzed, except for the evaluation of adverse events. The authors conclude that 0.3% ofloxacin otic solution is better than other otic antibiotic drops and other oral antibiotics in terms of overall cure rate and resolution of secondary outcome parameters. Estimates on the beneficial effects of ofloxacin otic solution are limited to the period of study included in this review.     

Tympanostomy tubes and otic drops

Otic drops have been proposed as a form of prophylaxis against the otitis media which follows middle ear contamination by water in patients with tympanostomy tubes. The potential adverse effects of this form of therapy were studied in chinchillas with tympanostomy tubes; 31 chinchillas underwent bilateral tympanostomy tube insertion. Seven animals had a mixture of green dye and Cortisporin otic suspension placed in both external auditory canals 24 hours following the placement of tympanostomy tubes and were sacrificed 30 minutes later for gross examination; 3 of these animals had previous eustachian tube obstruction with Silastic sponge. Twenty-one animals had Cortisporin otic suspension placed in the right external auditory canal on postoperative days 3, 4, 5, 6 and 7. No otic drops were placed in the left ear. Ten of these 20 animals had VIIIth nerve action potentials measured on postoperative day 17 and the other 11 animals had VIIIth nerve action potentials measured on postoperative day 42 followed by immediate sacrifice for histological examination and scanning electronmicroscopy. The remaining 3 animals had VIIIth nerve action potentials measured 21 days following tympanostomy tube insertion and served as electrophysiological controls. The 8 ears receiving Cortisporin otic drops mixed with green dye from animals with normal eustachian tubes showed staining of the round window membrane at sacrifice, while the 6 ears receiving Cortisporin otic suspension and green dye from animals with eustachian tube obstruction demonstrated no dye in the middle ear. All animals receiving Cortisporin otic drops in the right ear showed an intra-aural difference in action potentials with the right ear being attenuated by an average of 10.3 dB at 2,000 Hz, 12 dB at 4,000 Hz, 21 dB and 8,000 Hz, and 26 dB at 12,000 Hz. Morphological study revealed hair cell loss in the hook portion of the cochlea in those animals receiving Cortisporin otic drops. It was concluded from this study that, in patients with patent tympanostomy tubes in place, potentially ototoxic topical agents should be used with caution.     

Ofloxacin otic solution in patients with otitis media: an analysis of drug concentrations

OBJECTIVE: To measure the concentration of ofloxacin in otorrhea, serum, and middle ear mucosa after topical administration of 0.3% ofloxacin otic solution. DESIGN: Study of 0.3% ofloxacin otic solution administered in a single dose of 0.5 mL in adults or 0.25 mL in children with chronic suppurative otitis media and perforated tympanic membrane, with serial sampling of otorrhea and serum up to 8 hours after dosing and middle ear mucosa up to 2 hours after dosing. SETTING: Three hospitals in Kagoshima, Japan. PATIENTS: Thirty-eight patients (age range, 3-81 years) with chronic suppurative otitis media and perforated tympanic membrane; 20 patients had sampling of otorrhea and serum and 18 patients (who required middle ear surgery) had middle ear mucosa and serum sampling. RESULTS: High concentrations of ofloxacin were measured in otorrhea samples taken immediately after dosing, followed by a rapid, nonlogarithmic decline. Elimination of the drug through otorrhea was believed to be related to loss from the application site with ear drainage, rather than to biologic mechanisms. Maximum concentration of ofloxacin in otorrhea was seen at the initial sampling time, 30 minutes after dosing, with concentrations measured up to the last sampling at 8 hours. Very low concentrations of ofloxacin were found in serum after topical administration of the drug. Concentrations were not detected in serum samples of most of the patients. The highest concentration measured was 10 ng/mL. Drug concentrations were detected primarily in samples obtained up to 1 hour after the dose was administered. Mucosal drug concentrations were highly variable, ranging from nondetectable to 602 pg/g. For the 6 bacterial strains isolated from the middle ear, the highest minimum inhibitory concentration of ofloxacin was covered by otorrhea drug concentrations measured at up to 8 hours after dosing in some patients. No adverse events were observed. No clinically significant adverse changes in laboratory test results or audiometric results were observed. CONCLUSIONS: Drug concentrations were high in otorrhea, very low or not detected in serum, and highly variable in middle ear mucosa. Nonbiologic loss of the drug with the ear drainage through the external auditory canal and eustachian tube was probably related to the high concentration in otorrhea samples. Drug concentrations in middle ear mucosa suggest that the drug reaches the infection site.     

The necessity and effect of prophylactic quinolone ear drops after ventilation tube insertion for otitis media with effusion

BackgroundOtitis media with effusion (OME) is a condition where non-infective fluid builds up in the middle ear. Long-term OME can cause damage to the middle ear and hearing impairment. Ventilation tube insertion (VTI) is an efficient procedure to drain persistent OME. However, the effect of prophylactic ear drops after VTI remains controversial because no infection is present. This study investigated the need for and effect of quinolone ear drops in patients with OME after VTI.MethodsBetween July 2018 and July 2021, 272 patients (436 ears with OME) who underwent VTI were enrolled. Prophylactic quinolone ear drops (ofloxacin) were used in 271 OME ears and not used in 165. The clinical findings and effect of the ear drops were assessed.ResultsThe group with postoperative ofloxacin had less postoperative otorrhea (p < 0.001). In univariate analysis, age ≥ 13 years (odds ratio [OR] = 1.499, 95% confidence interval [CI]: 1.003–2.238, p = 0.046) was significantly associated with recovery to normal middle ear functioning (type A on postoperative tympanometry). No adenoid hypertrophy (OR = 1.692, 95% CI: 1.108–2.585, p = 0.014) and no postoperative otorrhea (OR = 2.816, 95% CI: 1.869–4.237, p < 0.001) were significant independent factors associated with middle ear recovery in both univariate and multivariate analysis. After VTI, 65% of tympanic membranes in the group with postoperative ofloxacin recovered to normal, while in 67% of tympanic membranes in the group without ofloxacin scarring remained.ConclusionsPatients who received prophylactic postoperative ofloxacin had less postoperative otorrhea. No adenoid hypertrophy and no postoperative otorrhea were significant independent predictors of middle ear recovery to normal function in both univariate analysis and multivariate analysis. However, prophylactic ofloxacin was not an independent predictor of normal middle ear functioning after VTI. After VTI, most OME patients who had used ofloxacin postoperatively had eardrums that were in better condition than those of patients who had not used ofloxacin. In this study, we confirmed the advantages and limitations of OME after VTI with prophylactic ofloxacin, thus providing clinicians with some guidance regarding the decision to administer prophylactic ofloxacin.     

Oxymetazoline vs ofloxacin vs ciprofloxacin/dexamethasone- effects of drops on tympanostomy tube postoperative otorrhea

ObjectiveTo assess for differences in postoperative otorrhea rates after tympanostomy with tube placement surgery comparing use of oxymetazoline, ofloxacin, or ciprofloxacin/dexamethasone drops prescribed in the postoperative period.MethodsA retrospective review was conducted of 516 pediatric patients who had either bilateral or unilateral myringotomy with tube placement performed during the year 2018. Information collected from each surgery included whether there was effusion at time of surgery, type of effusion, whether an adenoidectomy was performed the same time or prior, prior history of tube placement, style of tube placed, type of drop given or prescribed on the day of surgery. Demographic information including age, sex, race, weight was recorded as well. Finally, the postoperative visit was analyzed for presence of otorrhea in the ears that had surgery. Univariate analysis was conducted to see if there was any association between the three different drops and presence of otorrhea postoperatively.ResultsPostoperative otorrhea was present in 50 of the 516 patients (9.7 %). We observed no significant difference between the type of drop used and postoperative otorrhea being present (p = 0.179), but prior placement of tubes was significantly correlated to postoperative otorrhea (p < 0.001). There was no relationship between type of tube used, prior tube placement, or history of adenoidectomy with type of ear drop used.ConclusionOverall, there is no significant difference in the rate of postoperative otorrhea when choosing between oxymetazoline, ofloxacin, or ciprofloxacin/dexamethasone drops for use in the postoperative period after tympanostomy tube placement.     

Saline Irrigation in the Prevention of Otorrhea After Tympanostomy Tube Placement

Objectives: Comparison of intraoperative saline irrigation to otic drops in the prevention of postoperative otorrhea in children with middle ear effusion undergoing bilateral myringotomy with ventilation tubes. Study Design: This study was designed as a blinded, controlled, prospectively randomized trial. Methods: Study children were randomly assigned to receive either otic drops for 3 days postoperatively or saline irrigation of the middle ear space at the time of myringotomy. Only children with effusion present at the time of surgery were included. All children were evaluated for drainage 7 to 14 days postoperatively, and the degree of drainage was graded from 0 to 4. Results: Of the 84 patients entered into the study, 62 patients were eligible for data analysis (16 failed follow‐up, 6 records were lost). Of the patients who completed the study, not all had bilateral effusions, resulting in 111 ears for inclusion in the study. Fifty‐two ears underwent irrigation, and 10 were noted to have otorrhea (19.2%). Fifty‐nine ears received otic drops, resulting in 21 ears with otorrhea (35.6%). Evaluating the degree of otorrhea with a five‐point Leichert scale, the average score per ear was 0.42 for the saline irrigation group and 1.07 for the control group. The rate and degree of drainage were both statistically reduced in the saline irrigation group (P < .05). Conclusions: Using middle ear irrigation at the time of tympanostomy may be more effective than antibiotic drops in preventing postoperative otorrhea.     

Protective effect of corticosteroid against the cytotoxicity of aminoglycoside otic drops on isolated cochlear outer hair cells

OBJECTIVES: Otic drops are commonly used not only for otitis externa but also for otorrhea in the presence of tympanic membrane perforation or tympanostomy tube. Many studies demonstrated the ototoxicity of aminoglycoside. In our previous study, we observed that gentamicin (GM), when activated with liver extract, demonstrated significant cytotoxicity. The purpose of this study was to assess the protective effect of corticosteroid against the cytotoxicity of GM and tobramycin drops using isolated cochlear outer hair cells (OHCs) in vitro with liver extract. METHODS: OHCs from adult chinchilla cochleae were exposed to standard bathing solution, liver extract alone, and aminoglycoside otic drops with and without corticosteroid and liver extract. All experiments were performed at an osmolality of 305 +/- 5 mOsm, at room temperature, and for up to 60 minutes. The images of OHCs were recorded using an inverted microscope and analyzed on the Image Pro-Plus 3.0 program. Time to cell death and change of cell length were measured and analyzed. RESULTS: The time to cell death and percent change in cell length observed was significantly longer in the GM + liver extract + dexamethasone group than the GM + liver extract group (P <.05). The Tobradex + liver extract group showed an insignificant increase in percent change of cell length (P >.05) and significantly increased time to cell death than the tobramycin + liver extract group (P <.05). CONCLUSION: This study demonstrated that dexamethasone significantly reduced aminoglycoside cytotoxicity.     

Ciprofloxacin/dexamethasone drops decrease the incidence of physician and patient outcomes of otorrhea after tube placement

OBJECTIVE: To evaluate ciprofloxacin 0.3%/dexamethasone 0.1% (CIPRODEX, Alcon, Ft. Worth, TX) for the prevention of early post-operative otorrhea following TT placement. METHODS: This was a single-center, randomized, evaluator-blinded, parallel-group study. Two hundred children undergoing bilateral TT placement were categorized as having unilateral ("wet/dry"), bilateral ("wet/wet"), or no ("dry/dry") effusion at the time of surgery. All patients received Ciprodex or no treatment for 5 days post-operatively and returned at 2 weeks. RESULTS: Physician-observed otorrhea was reported in 5 (4.95%) patients receiving Ciprodex and 39 (39.39%) patients receiving no treatment (p<0.0001). Treatment decreased otorrhea in all groups, while the greatest benefit was observed in patients with bilateral effusion (93% reduction). Ciprodex treatment also decreased the rate of clinically diagnosed otitis media (OM) and effusion following TT placement (p< or =0.0006). CONCLUSION: Ciprodex reduced early post-operative otorrhea, clinically diagnosed OM and effusion following TT insertion. The greatest reduction in otorrhea was observed in patients with bilateral effusion at the time of surgery.     

Determination of ototoxicity of common otic drops using isolated cochlear outer hair cells.

OBJECTIVES: Otic drops are commonly used not only for otitis externa, but also for otorrhea in the presence of tympanostomy tubes or tympanic membrane perforations. Many studies have demonstrated the ototoxicity of common otic preparations such as Cortisporin otic drops (Monarch Pharmaceuticals, Bristol, TN). The purpose of this study was to assess the relative ototoxicity of common otic preparations by direct exposure to isolated cochlear outer hair cells (OHCs). METHODS: OHCs from adult chinchilla cochlea were exposed to standard bathing solution (control), acetic acid, Acetasol HC (Alpharma USPD Inc., Baltimore, MD), Gentacidin (CIBA Vision Ophthalmics, Atlanta, GA), and Tobradex (Alcon, Fort Worth, TX). The cells were observed using an inverted microscope, and the images were recorded in digital still-frame and video, and analyzed on the Image Pro-Plus 3.0 program (Media Cybernetics, Silver Spring, MD). RESULTS AND CONCLUSIONS: As measured by time to cell death and change in morphology of OHCs, acetic acid with or without hydrocortisone was most toxic to OHCs. Cortisporin was more cytotoxic than gentamicin and Tobradex.     

Topical ciprofloxacin/dexamethasone is superior to ciprofloxacin alone in pediatric patients with acute otitis media and otorrhea through tympanostomy tubes

OBJECTIVE: To determine whether topical administration of a corticosteroid improves resolution of acute tympanostomy tube otorrhea when combined with topical antibiotic drops. STUDY DESIGN: Randomized, patient-masked, parallel-group, multicenter trial of topical otic ciprofloxacin/dexamethasone versus topical ciprofloxacin alone in 201 children aged 6 months to 12 years with acute otitis media with tympanostomy tubes (AOMT) of less than or equal to 3 weeks' duration and visible otorrhea. METHODS: Eligible patients were randomized to receive three drops of either ciprofloxacin 0.3%/dexamethasone 0.1% or ciprofloxacin 0.3% into the affected ear or ears twice daily for 7 days. Clinical signs and symptoms of AOMT were evaluated on days 1 (baseline), 3, 8 (end-of-therapy), and 14 (test-of-cure), and twice-daily assessments of otorrhea were recorded in patient diaries. RESULTS: The mean time to cessation of otorrhea in the microbiologically culture-positive patient population (n = 167) was significantly shorter with topical ciprofloxacin/dexamethasone than with ciprofloxacin alone (4.22 vs. 5.31 days; P =.004). This resulted in significantly better clinical responses on days 3 and 8 (P <.0001 and P =.0499, respectively). However, there were no significant differences between the two treatment groups in either the clinical response or the microbial eradication rate by day 14. CONCLUSIONS: Topical otic treatment with ciprofloxacin/dexamethasone is superior to treatment with ciprofloxacin alone and results in a faster clinical resolution in children with AOMT. The contribution of the corticosteroid in achieving a 20% reduction (1.1 day) in time to cessation of otorrhea is clinically meaningful and represents an important advance over single-agent antibiotic therapy.     

Effects of common topical otic preparations on the morphology of isolated cochlear outer hair cells

Otic drops are commonly used not only for otitis externa but also for otorrhea in the presence of tympanostomy tube or tympanic membrane perforation. Many studies have demonstrated the ototoxicity of common otic preparations such as Cortisporin otic drops. Recent studies have suggested the use of fluoroquinolone antibiotic drops as an alternative owing to their excellent antimicrobial coverage and no ototoxic effect. The purpose of this study was to assess the relative ototoxicity of four common otic preparations by direct exposure to isolated cochlear outer hair cells (OHCs). OHCs from adult chinchilla cochlea were exposed to standard bathing solution (control), Cortisporin, Cipro HC, Ciloxan, and Floxin. The cells were observed using an inverted microscope, and the images recorded in digital still-frame and video, and analyzed on the Image Pro-Plus 3.0 program. As measured by time to cell death and change in morphology of OHCs, Cortisporin was most toxic to OHCs. Among the fluoroquinolone drops, Floxin was more toxic than Ciloxan or Cipro HC.     

Inflammatory effects of otic drops on the middle ear

Combination topical otic preparations are used to treat many infections of the external and middle ears. Despite the presence of ototoxic drugs in a number of these drops and convincing evidence of sensorineural hearing loss in humans and animal studies (Meyerhoff et al., presented at Southern Section Triological Meeting, Jan. 1983) following use of these medications, otic drops remain the cornerstone of treatment for many infectious disorders of the ear. Twelve chinchillas underwent bilateral tympanostomy tube placement and daily instillation of Cortisporin Otic Suspension (polymyxin B, neomycin, hydrocortisone, propylene glycol) in the right external auditory canal for 7 consecutive days. The animals were sacrificed 3 days later, 10 days following initiation of the Cortisporin Otic Suspension treatment. Following routine preparation of the temporal bones for light microscopy, the tissue was evaluated for evidence of inflammatory changes. All 12 animals demonstrated granulation tissue, effusion and focal hemorrhage in the ears subjected to the Cortisporin Otic Suspension. All of the contralateral control ears were normal. The present data suggest that this inflammatory response is due to a topical irritant effect of the otic preparation.     

Tube patency: Is there a difference following otic drop administration?

Purpose

Many surgeons instill peri-operative otic drops to maintain tube patency. A post-hoc analysis of three randomized, controlled studies involving a one-time administration of ciprofloxacin (OTO-201) given instead of otic drops perioperatively was conducted to evaluate tube patency in patients who did and did not receive otic drops as defined within the study protocol.

Gold laser versus curettage adenoidectomy: incidence of complications and otorrhea after concurrent pressure-equalization tube placement

OBJECTIVES: To measure the incidence of postoperative complications and otorrhea in patients undergoing Gold laser or curettage adenoidectomy with pressure-equalization (PE) tube placement. STUDY DESIGN: A prospective study of 100 patients, ages 8 to 48 months, undergoing Gold laser (n = 50) or curettage adenoidectomy (n = 50) and PE tube placement in a pediatric outpatient setting. METHODS: Pediatric patients with chronic otitis media with effusion and adenoid hypertrophy after failure of medical management were included in the study. Adenoid size and middle ear status were recorded at surgery. The total adenoidectomy procedure time was recorded. All patients were evaluated at 1 week, 1 month, and 4 months postoperatively. The incidence of nasal complications and otorrhea was recorded. RESULTS: There was no statistical difference in age, race, sex, adenoid size, or middle ear status between groups. The laser group had a shorter procedure time (P = .001) and a lower incidence of otorrhea (P = .024). There was no difference in nasal complications between groups. CONCLUSIONS: The Gold laser adenoidectomy technique can be safely performed with PE tube placement and may offer advantages over the traditional curettage adenoidectomy technique.     

Safety and efficacy of intratympanic ciprofloxacin otic suspension post-tubes in a real-world pediatric population

Purpose

Otorrhea frequently follows tympanostomy tube (TT) placement. We evaluated otorrhea following single 6 mg OTO-201 (OTIPRIO®, ciprofloxacin otic suspension 6%) intraoperative injection into each middle ear in a variety of effusion types and concurrent procedures in children undergoing TT placement. Secondary objective: Efficacy based on Medicaid status and safety.

A prospective study of infection following tympanostomy and tube insertion

An incidence of postoperative infection of up to 15 percent has been reported following middle ear ventilation tube surgery. This rate of complication would be considered unacceptable following most other operative procedures. A controlled prospective study of 107 children undergoing tympanostomy and tube surgery over a 1-year period was undertaken. Subjects were randomly assigned to receive antibiotic-steroid otic drops at the time of surgery and for 1 week afterward, oral ampicillin for 24 hours preceding and 3 days following surgery, or no prophylactic treatment. The overall infection rate within four weeks of surgery was 12 percent. Purulent otorrhea occurred in 18 percent of those receiving no prophylactic treatment, in 13 percent receiving ampicillin, and in 6 percent receiving antibiotic-steroid otic drops. Postoperative infection was related to preoperative history of status otitis media and to previous placement of ventilation tubes.     

Preventive therapy for postoperative purulent otorrhea after ventilation tube insertion

OBJECTIVE: Treatment modalities which are intraoperative irrigation of the middle ear with isotonic saline, postoperative oral antibiotic treatment, and postoperative topical antibiotic use have been compared with each other and with control group regarding their efficiency in preventing postoperative purulent otorrhea after ventilation tube insertion. Moreover, the costs of the treatment modalities were analyzed. STUDY DESIGN: Each group consisted of 70 patients, and a total of 280 patients were followed up for purulent otorrhea 2 weeks after the surgery. The study was a single-blind randomized clinical trial. RESULTS: Ten (14.28%) patients in the oral antibiotic group, 11 (15.71%) patients in the isotonic saline irrigation group, 6 (8.57%) patients in the topical antibiotic drops group, and 21 (30%) patients in the control group had postoperative purulent otorrhea. Statistical analysis determined a significant difference between each treatment modalities and control group but did not show any significant difference between the treatment groups. When the treatment options were compared according to their cost, however, the cost per successfully treated patient was significantly lower in the saline irrigation group. CONCLUSION: Intraoperative saline irrigation of the middle ear provides an effective, easy, and cheap treatment in preventing postoperative purulent otorrhea.     

Repair of large traumatic tympanic membrane perforation using ofloxacin otic solution and gelatin sponge

IntroductionTraumatic large tympanic membrane perforations usually fail to heal and require longer healing times. Few studies have compared the healing and hearing outcomes between gelatin sponge patching and ofloxacin otic solution.ObjectivesTo compare the healing outcomes of large traumatic tympanic membrane perforations treated with gelatin sponge, ofloxacin otic solution, and spontaneous healing.MethodsTraumatic tympanic membrane perforations >50% of the entire eardrum were randomly divided into three groups: ofloxacin otic solution, gelatin sponge patch and spontaneous healing groups. The healing outcome and hearing gain were compared between the three groups at 6 months.ResultsA total of 136 patients with large traumatic tympanic membrane perforations were included in analyses. The closure rates were 97.6% (40/41), 87.2% (41/47), and 79.2% (38/48) in the ofloxacin otic solution, gelatin sponge patch, and spontaneous healing groups, respectively (p = 0.041). The mean times to closure were 13.12 ± 4.61, 16.47 ± 6.24, and 49.51 ± 18.22 days in these groups, respectively (p < 0.001).ConclusionsGelatin sponge patch and ofloxacin otic solution may serve as effective and inexpensive treatment strategies for traumatic large tympanic membrane perforations. However, ofloxacin otic solution must be self-applied daily to keep the perforation edge moist, while gelatin sponge patching requires periodic removal and re-patching.     

Ototoxicity of otic drops applied to the middle ear in the chinchilla

Previous studies have shown that the application of topical otic drops to the external ear canals of animals with patent tympanostomy tubes may result in hearing impairment and cochlear hair cell loss. Otic drops are used in patients with tympanostomy tubes or tympanic membrane perforations and could have deleterious effects on the human membranous labyrinth. This report describes the inner ear damage that occurred after direct application of aminoglycoside-containing otic drops to the middle ears of experimental animals. The membranous labyrinths of 25 chinchillas were studied two days to five months after application of Cortisporin otic suspension (which contains neomycin, polymyxin B, hydrocortisone, and propylene glycol) to the middle ear cavity. Application of 0.5 ml of Cortisporin resulted in degeneration of all inner and outer hair cells throughout the cochlea, as well as severe damage to the stria vascularis. Moderate to severe degeneration of the vestibular receptor organs was also observed. The endolymphatic sacs showed dark-staining endolymph, cellular debris, and macrophages in the sac lumina, as well as increased activity of the epithelial lining.     

Improving the penetration of ototopicals through tympanostomy tubes: role of surfactants

OBJECTIVE: To evaluate the ability of surfactants to increase the penetration of ototopicals through tympanostomy tubes (TT). METHODS: An in vitro model was used to test the penetration of ototopicals with and without two surfactants (docusate sodium and beractant) through fluoroplastic and titanium TTs. The model was created by placing a TT through a perforation (myringotomy) in a model of the tympanic membrane (silastic sheet) fixed between the ends of two 1 mL syringes. Measurements were recorded of the maximum height various solutions (distilled water, soapy water, ofloxacin otic, ciprofloxacin/dexamethasone otic) achieved before penetrating the TTs (1.27 mm Reuter Bobbin titanium, 1.27 mm fluoroplastic). These same measurements were then performed with the addition of docusate sodium or beractant to the distilled water and each of the ototopical solutions. RESULTS: The addition of docusate sodium significantly increased the penetration of water and ofloxacin otic through both types of TTs. It significantly increased penetration of ciprofloxacin/dexamethasone otic through fluoroplastic tubes with a trend towards increased penetration through titanium tubes. Adding beractant showed a modest trend toward increasing the penetration of both ototopicals in fluoroplastic tubes which did not reach statistical significance. CONCLUSIONS: These results demonstrate that the penetration of ototopicals through TTs can be improved by the addition of surfactants. Increasing the penetration of ototopicals may make them more effective in treating TT otorrhea. However, we strongly discourage clinicians from using these compounds clinically until their safety has been established.