A Prospective, Randomized Trial of Povidone-Iodine 0.6% and Dexamethasone 0.1% Ophthalmic Suspension for Acute Bacterial Conjunctivitis.

PURPOSE: To evaluate the efficacy and safety of a topical ophthalmic suspension combination of povidone-iodine 0.6% (PVP-I) and dexamethasone 0.1% (DEX) for infectious and inflammatory components of bacterial conjunctivitis. DESIGN: Randomized, double-masked, multicenter, phase 3 clinical trial. METHODS: Subjects of all ages (those <3 months had to be full-term) with a diagnosis of bacterial conjunctivitis were randomized 3:1:3 to either PVP-I/DEX, PVP-I alone, or placebo. The primary endpoint was clinical resolution in the study eye, and the key secondary efficacy endpoint was bacterial eradication, both at the day 5 visit. Adverse events (AEs) were documented at all visits. RESULTS: Overall, 753 subjects were randomized (intent-to-treat [ITT] population; PVP-I/DEX [n = 324]; PVP-I [n = 108]; placebo [n = 321]); mean and standard deviation (SD) age was 44.3 (22.9) years, and most were female (61.2%) and white (78.1%). In all treatment groups, mean treatment compliance was >98%. The modified ITT population for the efficacy analysis comprised 526 subjects. In the study eye at the day 5 visit, clinical resolution was achieved by 50.5% (111/220) subjects in the PVP-I/DEX group vs 42.8% (95/222) in the placebo group (P = .127), and bacterial eradication was achieved by 43.3% (94/217) and 46.8% (102/218), respectively (P = .500). Treatment-emergent AEs were experienced by 32.8% (106/323), 39.8% (43/108), and 19.0% (61/321) of subjects in the safety population treated with PVP-I/DEX, PVP-I, and placebo, respectively (most mild in severity). CONCLUSION: In this study, PVP-I/DEX did not demonstrate additional benefit in clinical efficacy compared with placebo in subjects with bacterial conjunctivitis.

Bacterial infection in scarring trachoma.

PURPOSE: To assess whether non-chlamydial bacterial infection is associated with trachomatous scarring in adults. METHODS: This was a case-control study of 360 cases with trachomatous scarring but without trichiasis, and 360 controls without scarring. All participants underwent clinical examination, and a swab was taken from the inferior conjunctival fornix. Samples were inoculated onto blood and chocolate agar later that day. RESULTS: Bacterial isolates were identified in 54.0% of cases compared with 34.6% of controls (P < 0.001). A multivariate logistic regression model adjusted for age and lack of education showed that scarring was associated with the presence of commensal organisms (odds ratio [OR], 1.46; 95% confidence interval [CI], 1.01-2.09) and was strongly associated with the presence of pathogenic organisms (OR, 4.08; 95% CI, 1.59-10.45). There was an increasing prevalence of all bacterial isolates with increasing severity of scarring (P(trend) < 0.001). CONCLUSIONS: Trachomatous scarring is strongly associated with non-chlamydial bacterial infection compared with controls. The role of such infection with regard to scarring progression should be investigated and may have important implications for trachoma control strategies and prevention of blindness.

Limitations of current antibiotics for the treatment of bacterial conjunctivitis.

Bacterial conjunctivitis is a common ocular infection that is generally treated empirically with a broad-spectrum antibiotic. The more common pathogens causing bacterial conjunctivitis include Staphylococcus aureus, Haemophilus influenzae, Streptococcus pneumoniae, Staphylococcus epidermidis, and Moraxella species. Several antibiotics traditionally used to treat bacterial conjunctivitis are no longer widely prescribed because of increased bacterial resistance and/or safety concerns. The introduction of the fluoroquinolone class of anti-infectives offered effective and better tolerated treatment options. Nonetheless, successful therapy for bacterial conjunctivitis continues to be limited by several factors. A primary concern is the development of bacterial resistance that may be impacted not only by widespread antibiotic use but also by antibacterial pharmacokinetics, such as maintenance of insufficient bactericidal concentrations at the site of infection. In addition, poor adherence to prescribed regimens that require frequent administration, along with undesirable adverse events, affects the development of bacterial resistance and the success of treatment regimens. This article reviews current antibacterial agents used to treat bacterial conjunctivitis, factors that limit their successful use in treatment, and options for future development of more effective topical ophthalmic anti-infective agents.

Safety and tolerability of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis: data from six clinical and phase I safety studies.

BACKGROUND: Besifloxacin is a novel fluoroquinolone, specifically a chloro-fluoroquinolone, with potent broad-spectrum bactericidal activity for the topical treatment of bacterial conjunctivitis. OBJECTIVE: The objective of this report was to provide a comprehensive assessment of the safety and tolerability of besifloxacin ophthalmic suspension 0.6% across clinical and phase I safety studies. METHODS: Data were drawn from two phase I safety studies in healthy adults, an open-label, phase II pharmacokinetic study of patients with bacterial conjunctivitis and from integrated data from three randomized, double-masked, parallel-group, safety and efficacy studies of patients with bacterial conjunctivitis (two were vehicle controlled and one was active controlled with moxifloxacin ophthalmic solution 0.5%, as base). Safety assessments included changes in visual acuity, ocular assessments with ophthalmoscopy and biomicroscopy, and assessment of adverse events (AEs). RESULTS: Safety data for besifloxacin ophthalmic suspension 0.6% were available for 1350 patients, including 1192 patients (1810 eyes) in the integrated analysis. Systemic exposure following topical administration of besifloxacin ophthalmic suspension 0.6% was negligible. No changes were seen in corneal endothelial cell density. In the integrated safety analysis of the three safety and efficacy studies, the most commonly reported ocular AEs in study eyes receiving besifloxacin ophthalmic suspension 0.6% were blurred vision (2.1%), eye pain (1.8%), eye irritation (1.4%), nonspecific conjunctivitis (1.2%) and eye pruritus (1.1%). Blurred vision, eye irritation and nonspecific conjunctivitis occurred in significantly fewer besifloxacin-treated patients than in vehicle-treated patients (p < or = 0.05). Headache (1.8%) was the most frequently reported non-ocular AE. Most AEs were mild in severity and there were no treatment-related serious AEs. Besifloxacin ophthalmic suspension 0.6% did not significantly affect visual acuity, biomicroscopy or ophthalmoscopy compared with vehicle or moxifloxacin. CONCLUSION: The results from this comprehensive data set of 1350 patients demonstrate that besifloxacin ophthalmic suspension 0.6% has a favourable safety profile and is well tolerated.

[Efficacy assessment of azithromycin 1.5% eye drops versus tobramycin 0.3% on clinical signs of purulent bacterial conjunctivitis]. / Evaluation de l'efficacité d'un collyre azithromycine 1,5% versus tobramycine 0,3% sur les signes cliniques de la conjonctivite bactérienne purulente.

INTRODUCTION: Bacterial conjunctivitis is characterized by hyperemia and discharge of one or both eyes. These clinical signs appear quickly and are contagious. This study compares the clinical efficacy (signs and symptoms) and safety of azithromycin 1.5% eye drops with tobramycin 0.3%. PATIENTS AND METHODS: This was a multicenter, randomized, investigator-masked study including 1,043 patients with purulent bacterial conjunctivitis. Patients received either azithromycin twice daily for 3 days or tobramycin, 1 drop every 2 hours for 2 days, then four times daily for 5 days. The primary variable was clinical cure at the test-of-cure (TOC) visit (D9) on the worst eye. The cure was defined as bulbar conjunctival injection and discharge scores of 0. Clinical signs were evaluated at D0, D3, and D9. RESULTS: In the azithromycin group 87.8% of patients and in the tobramycin group 89.4% were clinically cured at D9. Clinical cure with azithromycin was not inferior to tobramycin at D9: discharge was absent in 96.3% of patients treated with azithromycin and 95.1% with tobramycin. Azithromycin was well tolerated. CONCLUSIONS: Azithromycin 1.5% for 3 days (six drops) was as effective as tobramycin for 7 days (36 drops). Furthermore, patients on azithromycin presented earlier clinical cure on Day 3 than patients on tobramycin. Azyter, with its convenient dosing (bid for 3 days), is a step forward in the management of purulent bacterial conjunctivitis.

A tularemia outbreak in an extended family in Tokat Province, Turkey: observing the attack rate of tularemia.

OBJECTIVE: We report the first tularemia epidemic occurring in Tokat Province, located in the Middle Black Sea Region of Turkey, and some features of the cases. This epidemic has allowed the calculation of the attack rate of this disease because of its appearance in a single large family. METHODS: The clinical and laboratory features of patients were examined. For serological diagnosis, microagglutination assays were done on serum samples from patients and other members of the family. RESULTS: Seven members of the family developed overt clinical disease (one ulceroglandular, six oropharyngeal). Three patients had conjunctivitis in addition to oropharyngeal involvement. All patients had a microagglutination titer above 1/160. As eight out of 16 members of the extended family were found to be positive for tularemia serology, the attack rate was calculated to be 50%. CONCLUSIONS: Tularemia is highly infectious and different clinical forms can occur in a single epidemic.

Bacterial conjunctivitis: a review for internists.

Bacterial conjunctivitis is common and occurs in patients of all ages. Typical signs are a red eye and purulent drainage that persists throughout the day. Gonococcal and chlamydial conjunctivitis must be treated with systemic antibiotics. Bacterial conjunctivitis due to most other organisms can be treated empirically with topical antibiotics. Red flags suggesting a complicated case requiring referral to an ophthalmologist include reduced vision, severe eye pain, a hazy-appearing cornea, contact lens use, and poor response to empirical treatment.

Acute bacterial conjunctivitis.

Acute bacterial conjunctivitis is the eye disease most commonly seen by general practitioners, and is estimated to represent approximately 1% of all consultations in primary care. This article gives a review of the epidemiology, aetiology, clinical picture, complications, differential diagnoses, in vitro examinations and therapy of acute bacterial conjunctivitis. Until now, topical antibacterial therapy has generally been preferred by both physicians and patients because this will usually shorten the course of the disease slightly and allow the early readmittance of children to their kindergarten or school. Recently, several reports from primary care have confirmed the well-known clinical experience that the disorder has an excellent prognosis with a high frequency of spontaneous remission. In accordance, an expectant attitude or delayed prescription policy are now frequently strongly recommended. However, these reports also emphasize the difficulty in making a correct clinical distinction between bacterial and viral conjunctivitis. The effect of a general non-prescription attitude on transmission rates of pathogens also remains to be clarified. This must be born in mind when deciding how these patients should be handled. The socioeconomic and medical pros and cons of different treatment policies are discussed, and a highly personal view on the optimal handling strategy for these patients is also presented.

Bacterial infection and trachoma in the gambia: a case control study.

PURPOSE: Trachoma is the leading infectious cause of blindness worldwide. Conjunctival scarring is initiated by recurrent Chlamydia trachomatis infection. However, disease progression to trichiasis occurs even in regions where chlamydial prevalence is currently low, which suggests that other factors, for example other bacterial infection, may also drive inflammation and scarring, particularly in the late stages of trachoma. This study was undertaken to investigate whether trachomatous trichiasis or conjunctival scarring are associated with increased prevalence of bacterial infection. METHODS: Within a case-control study design, individuals with trichiasis or conjunctival scarring (without trichiasis) were compared with normal matched control subjects. Subjects were examined for signs of trachoma. Conjunctival swab samples were collected for bacteriologic culture and C. trachomatis PCR. RESULTS: Recruited for the study were 121 trichiasis case-control pairs and 117 conjunctival scarring case-control pairs. Eyes with trichiasis were more frequently infected with bacteria (37%) than were normal control eyes (7%) (OR: 8.2; P < 0.001; 95% CI: 3.24-20.8). Bacterial infection was more common with increased trichiasis severity. In the conjunctival scarring case-control group, scarred eyes had slightly more bacterial infection (11%) than did normal control eyes (6%), although this was not significantly different (OR: 2.2; P = 0.144; 95% CI: 0.79-6.33). CONCLUSIONS: Trichiasis is associated with increased risk of bacterial infection, and there may be a similar trend in eyes with conjunctival scarring. Bacterial infection of the conjunctiva is associated with inflammation, which may result in progressive scarring. Prospective studies are needed to determine the contribution of bacterial infection to disease progression. Bacterial infection probably also contributes to the development of corneal opacification.

A community outbreak of conjunctivitis caused by nontypeable Streptococcus pneumoniae in Minnesota.

BACKGROUND: The Minnesota Department of Health (MDH) was notified of an outbreak of conjunctivitis in city A with cultures positive for Streptococcus pneumoniae. METHODS: MDH staff contacted clinics and schools in city A and city B regarding conjunctivitis cases, reviewed clinical findings of conjunctivitis cases in city A and collected isolates for subtyping. RESULTS: Between September 1 and December 12, 2003, cities A and B reported 735 conjunctivitis cases. Fifty-one percent of the cases were reported from schools, childcare centers and colleges. Adults were more likely to report itching, burning or swelling of the eye(s); children were more likely to report crusty eyes (P < 0.05). Forty-nine percent of conjunctival cultures (71 of 144) were positive for S. pneumoniae. All isolates were nontypeable by serotyping. Pulsed field gel electrophoresis identified 3 clonal groups with 84% of isolates belonging to one clonal group. Multilocus sequence typing revealed that isolates had the same multilocus sequence type as isolates from a 2002 outbreak at a New England college. CONCLUSIONS: This outbreak was widespread in the community and conjunctivitis clinical presentation varied by age. The predominant strains in this outbreak were related to a pneumococcal strain implicated in prior conjunctivitis outbreaks, suggesting these strains have a predilection for causing conjunctivitis.

Susceptibility of alpine ibex to conjunctivitis caused by inoculation of a sheep-strain of Mycoplasma conjunctivae.

We evaluated the susceptibility of alpine ibex (Capra ibex ibex) to mycoplasmal conjunctivitis induced by a strain of Mycoplasma conjunctivae isolated from domestic sheep by inoculation of three alpine ibexes with 1.2 x 10(6) colony forming units of M. conjunctivae in the conjunctival sac of both eyes. One more ibex was exposed to the infection by contact. Experimental animals were free of M. conjunctivae and ocular Chlamydia infection before inoculation. Conjunctivitis and serous to mucous lachrymation became apparent in all four ibexes. Clinical signs began within 2 days in inoculated animals and 22 days after the beginning of the experiment in the contact ibex. M. conjunctivae was demonstrated up to the 63th day post-inoculation by cultural and PCR-methods. After 63 days, histopathologic examination revealed nearly normal ocular tissues, and M. conjunctivae could be detected from two eyes only. No other infectious agents which might cause conjunctivitis or keratitis, including Chlamydia psittaci and Branhamella ovis, were involved. Our investigation indicates that sheep-strains of M. conjunctivae can induce conjunctivitis in alpine ibex, thus showing pathogenicity of this organism for Caprinae species other than domestic sheep and goats.

Characterization of Neisseria meningitidis isolates and clinical features of meningococcal conjunctivitis in ten patients.

Cases of meningococcal conjunctivitis occurring in Denmark in the period 1982-1991 were reviewed. In a survey of laboratory reports, ten cases were identified. The meningococcal strains were characterized by serological grouping, typing and subtyping, and by antimicrobial susceptibility testing. Five cases were caused by serogroup B meningococci (B:15:P1.16, B:15:P1.6, B:4:P1.15) and five cases by serogroup C meningococci (C:2a:P1.2 (4 strains), C:14:NST). The median age of the patients was 12.5 months (range 7 days to 9 years). Signs of conjunctivitis were predominant; in addition, five of the patients had fever and general malaise. In one patient the same strain was recovered from blood and eye secretions. None of the patients had signs of meningitis. All meningococcal strains isolated from patients with meningococcal conjunctivitis were assumed to be virulent and had the same characteristics as strains causing meningococcal disease in Denmark within the same period.

Chlamydial conjunctivitis in neonates and adults. History, clinical findings and follow-up.

This study presents data from 73 neonatal and 60 adult patients with chlamydial conjunctivitis who were studied by culture, enzyme-linked immunosorbent assay (ELISA) and immunofluorescence (IF) tests. All patients had visited three or more doctors before the diagnosis was established. Fourteen of the adults had consulted an ophthalmological emergency unit complaining of a foreign body sensation in the eye. The symptoms started monocularly in all 133 cases, however, the fellow eye was affected after 2-7 days in 54 of the neonates and in 5-30 days in 20 of the adult patients. The duration of symptoms before the etiological diagnosis was established was 5-198 days (mean 24 and median 15 days) in the neonates and 7-120 (mean 29 and median 22 days) in the adults. The conjunctivitis was mild, moderate and severe in 7, 72 and 48 of the neonatal eyes, when the etiological diagnosis was established. The corresponding figures for severity of conjunctivitis in the adult group were 9, 57 and 14. Nasopharyngeal colonization occurred in 56 (77%) of the children and in 35 (58%) of the adults. In the adults, only two males complained of symptoms of genital infection. In 46 (77%) adults one or more of the chlamydial diagnostic tests performed on genital samples was positive for Chlamydia trachomatis. Forty-five of the neonates were treated with erythromycin 40-50 mg per kg body weight divided in four daily doses for 14 days, while 35 of the adults were given 250 mg x 4 x 14 of erythromycin.(ABSTRACT TRUNCATED AT 250 WORDS)

Viral and bacterial conjunctivitis. Prevention of disastrous results.

Conjunctivitis has many bacterial and viral causes. If the cause is bacterial, treatment with a broad-spectrum antibiotic resolves the problem in 1 to 3 days in almost all cases. If signs and symptoms persist, referral to an ophthalmologist is wise. Most cases of viral conjunctivitis are accompanied by follicular reactions in the inferior fornix, as observed with adult inclusion disease. If dendrites are seen, trifluridine (Viroptic) is preferred for treatment. Referral to an ophthalmologist is advisable because recurrence with scarring and permanent loss of vision is possible. Many topical antibiotics include a corticosteroid component that never should be used unless the conjunctivitis or keratitis is proven to be nonherpetic.