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Purpose: This randomized, investigator-masked study aimed to compare the clinical and microbiological effectiveness of three times daily administration of levofloxacin 0.5% eyedrops with the classic, more frequent dosing in patients with bacterial conjunctivitis., Methods: A total of 120 patients with symptoms of bacterial conjunctivitis were enrolled. The patients were randomly assigned to receive 0.5% levofloxacin eyedrops three times daily to each eye for 5 days (experimental dosage group), or every 2 hours on days 1 and 2, and then every 4 hours on days 3-5 (up to four times per day) (classic dosage group). Ocular symptoms and signs were assessed on day 1, days 3 to 4, and 7 +/- 1 visits. Conjunctival cultures were obtained at baseline and final visits. Clinical outcomes were based on resolution of cardinal signs. Microbial outcomes were based on culture results., Results: Eighty-six patients (41 experimental dosage, 45 classic dosage) were evaluated. There was no difference between the groups in frequency of patients with clinical outcome resolved (85.4% in experimental vs 93.3% in classic dosage group, p=0.3). The microbial eradication rates did not differ statistically between the groups (92.7% vs 95.6%, respectively, p=0.67)., Conclusions: There was no statistically significant difference in the efficacy or safety between the two methods of drug administration. Analysis of the results of compliance supported our conclusion that the less frequent method of dosing of 0.5% levofloxacin eyedrops was more convenient for patients and resulted in better adherence to the drug-dosing scheme.

Purpose: Antibacterial efficacy of topically applied azithromycin 1.5% was compared with tobramycin 0.3% in a multicenter, randomized, investigator-masked study for the treatment of purulent bacterial conjunctivitis., Methods: A total of 1043 adults and children received either azithromycin twice daily for 3 days (n=524) or tobramycin every 2 hours while awake for 2 days, then four times daily for 5 days (n=519). Conjunctival swabbing was taken at days 0, 3, and 9, using alginate swabs resuspended in a dissolution-transport medium, providing rapid and reproducible results. Cagle's criteria were used to define the pathogenicity level for each isolated bacterium., Results: In the per-protocol set, the rate of bacteriologic resolution was 85.2% for azithromycin versus 83.8% for tobramycin on day 3, and 92.8% for azithromycin versus 94.6% for tobramycin on day 9. Azithromycin was demonstrated to be noninferior to tobramycin according to the 10% noninferiority margin. Although some bacteria were categorized as resistant to tested antibiotics, eradication was observed (for azithromycin: Acinetobacter, Enterobacteriaceae, Pseudomonas), highlighting the specific pharmacokinetics/pharmacodynamics of the ocular route., Conclusions: In total, topical therapy with azithromycin 1.5% administered only twice daily for 3 days effectively eradicates most pathogenic bacteria associated with bacterial conjunctivitis. These microbiologic results are in accordance with the observed clinical outcome. This new anti-infective product has the advantage of a short treatment course which could lead to an improvement in patient compliance.

Purpose: To compare the safety and efficacy of a new enhanced viscosity ophthalmic formulation of tobramycin, given twice daily (BID), with the existing four times daily (QID) treatment regimen in patients with acute bacterial conjunctivitis., Methods: This was a 12-day, multicenter, observer-masked, randomized, parallel group study. Patients received one drop of tobramycin 0.3% (3 mg/mL) enhanced viscosity ophthalmic solution BID or tobramycin 0.3% (3 mg/mL) ophthalmic solution QID in the affected eyes for 7 days. The primary efficacy variable was the percentage of patients with sustained cure/presumed bacterial eradication based on clinical judgment at the test-of-cure visit (Day 12). Pretherapy bacterial isolates were obtained and tested for susceptibility to tobramycin by determination of minimum inhibitory concentrations (MIC)., Results: A total of 276 patients were enrolled in the study and 203 of these were culture positive and attended all follow-up examinations. In this group, 98% of those treated with tobramycin enhanced viscosity ophthalmic solution and 99% of those treated with tobramycin 0.3% ophthalmic solution were categorized as having sustained cure/presumed eradication at the test-of-cure visit (p = 0.6037). Reported adverse events were not serious, mild to moderate in severity, and generally did not prevent continuation in the study. Several pre treatment pathogens demonstrated tobramycin resistance (MIC > 4 mg/mL). However, therapy with both treatments was effective in the majority of the cases., Conclusions: Tobramycin enhanced viscosity ophthalmic solution is well tolerated and has equivalent efficacy to the established treatment regimen with a simplified posology. The formulation provides an alternative therapy for acute bacterial conjunctivitis that should improve patient compliance and satisfaction.

Purpose: The main purpose of this prospective study was to compare the efficacy, local tolerance, and safety of topical lomefloxacin 0.3% and topical ofloxacin 0.3% in the treatment of acute bacterial conjunctivitis., Patients and Methods: Forty patients with acute bacterial conjunctivitis were included in a randomized, prospective, parallel-group study. Twenty patients were assigned to the lomefloxacin group (Okacin, CIBA Vision Ophthalmics) and 20 patients to ofloxacin (Oflox, Allergan). Lomefloxacin 0.3% was given 1 drop every 2 hours during waking hours on the first day then twice daily for one week. Ofloxacin 0.3% eyedrops were given four times daily. All patients underwent eye examination and clinical findings were graded and recorded according to severity of lid hyperemia, lid edema, lid crusting, conjunctival edema and discharge, bulbar conjunctival hyperemia, palpebral conjunctival hyperemia, corneal edema, and ocular discomfort. The score for each clinical sign was recorded before and after treatment. The mean cumulative sum score (CSS) was obtained by adding the scores for signs and symptoms. All conjunctival swabs were cultured and tested for sensitivity. Patients with confirmed bacterial conjunctivitis were included., Results: There were 10 male and 10 female patients in each group. The age range was from 1 to 78 years, and the mean age was 35 years in the lomefloxacin group. In the ofloxacin group the age range was from 1 to 70 years, and the mean age was 26 years. There was no significant difference between the two groups in relation to age or sex. The causative organisms were Staphylococcus epidermidis in 16 cases (36%), alpha-hemolytic Streptococci in 9 (20%), Haemophilus spp. 6 (13%), Staphylococcus aureus 5 (11%), Streptococcus pneumoniae 4 (9%), Pseudomonas aeruginosa 3 (7%), and other 2 (4%). The mean CSS for conjunctivitis was 12.1 before therapy in the lomefloxacin group and 12.7 in the ofloxacin group. On the 7th day of therapy, the mean CSS was 0.7 in the lomefloxacin group, and 1.6 for ofloxacin. All patients showed improvement, but a total of 18 out of 20 (88%) in the lomefloxacin group showed complete resolution compared to 15 (75%) in the ofloxacin group. The difference was not statistically significant (p = 0.08). Tolerance was excellent in both groups, and no side effects were reported. A burning sensation was noted by two patients, one in each group., Conclusions: Lomefloxacin and ofloxacin were equally effective and safe in the treatment of acute bacterial conjunctivitis.

The efficacy and safety of ciprofloxacin ophthalmic solution (0.3%) and fusidic acid gel (1%) were compared in the treatment of bacterial conjunctivitis and blepharitis in a randomized, open, parallel group study. Thirty-nine patients, 21 treated with ciprofloxacin solution and 18 treated with fusidic acid gel, were culture-positive on admission and were evaluable for efficacy. At the end of a 7-day treatment, the infecting organism was eradicated in 81% of those treated with ciprofloxacin and 72% of those treated with fusidic acid gel. There was clinical cure or improvement in 95% and 89% respectively. The clinical cure rate appeared to be higher with ciprofloxacin than fusidic acid (62% compared with 28%) but this was related to the higher proportion of patients with acute conjunctivitis in the ciprofloxacin group. Two patients using ciprofloxacin had mild discomfort and stinging on instillation and one given fusidic acid had moderate edema and discomfort; the latter patient stopped treatment. Topical ciprofloxacin is effective and well tolerated and is a useful treatment of bacterial conjunctivitis and blepharitis.

The effects of four days' treatment with topical Maxitrol (neomycin sulphate 3500 IU/mL, polymyxin-B sulphate 6000 IU/mL with dexamethasone 0.1%) were compared with those of Maxidex (dexamethasone 0.1% alone) in a double-masked study in 111 patients with bacterial blepharitis or conjunctivitis, 95 of whom were evaluable for efficacy. The majority of patients (N = 80) had chronic blepharitis. Maxitrol treatment resulted in a significantly greater reduction (90%) in bacterial counts and bacterial eradication (50%) compared with Maxidex (34% and 17% respectively). Maxitrol treatment also produced a significantly greater reduction in conjunctival discharge than did Maxidex, while the treatments were equally effective in alleviating other ocular signs and symptoms. It was concluded that use of a fixed dose combination steroid-antibiotic product was more effective for bacterial control and therapeutic efficacy in the treatment of chronic blepharitis and conjunctivitis patients than treatment with steroid alone. However, in the long-term treatment of chronic blepharitis the well-known toxic problems of neomycin sulphate have to be taken into account.

The efficacy and safety of ciprofloxacin ophthalmic solution 0.3% and norfloxacin ophthalmic solution 0.3% in the treatment of bacterial conjunctivitis and blepharitis were compared in a double masked randomised study. A total of 131 patients, 65 treated with ciprofloxacin (42 with conjunctivitis and 23 with blepharitis) and 66 treated with norfloxacin (39 with conjunctivitis and 27 with blepharitis) were enrolled in the study at five centres in France. In the efficacy population, pathogens were eradicated or reduced in 96% (24/25) of patients in the ciprofloxacin group and 89% (24/27) in the norfloxacin group. There was no difference between treatments with regard to eradication of particular pathogens. In the efficacy population, clinical cure or improvement was seen in 96% of the patients (24/25 in the ciprofloxacin group and 26/27 in the norfloxacin group). There were no significant differences between ciprofloxacin and norfloxacin with respect to improvements in four symptoms or ten clinical signs. No serious treatment-related adverse events were reported and both ciprofloxacin and norfloxacin were well tolerated.

The efficacy and safety of ciprofloxacin (0.3%) ophthalmic solution and rifamycin (1%) ophthalmic solution for the treatment of bacterial conjunctivitis and blepharitis was compared in this randomized, double-masked, parallel-group study. Forty-one patients, 19 on ciprofloxacin and 22 on rifamycin, were culture-positive on admission and evaluated for efficacy. There was clinical improvement in more than 90% of patients in each group at the end of the seven-day treatment period. However, clinical cure rates on day 7 appeared to be higher with ciprofloxacin (53%) than rifamycin (23%; p = 0.061, Mann-Whitney test). Bacteriological eradication rates were comparable: the infecting organisms were eradicated in 68% of patients on ciprofloxacin and 77% with rifamycin. There were no serious adverse reactions to either treatment. One patient in each group was withdrawn on account of a mild allergy. In conclusion, topical ciprofloxacin was effective and well tolerated and would be a particularly useful agent for the treatment of bacterial conjunctivitis and blepharitis.

An international multicentre study assessed the clinical and antibacterial efficacy of a new topical ophthalmic formulation of the quinolone antimicrobial agent ciprofloxacin and compared it with that of tobramycin ophthalmic solution in patients with blepharitis and blepharoconjunctivitis. The study consisted of a randomised double-masked between-group evaluation of 464 patients, 230 of whom were treated with ciprofloxacin and 234 with tobramycin. There was qualitative and quantitative bacteriology, and clinical assessment of ocular symptoms and signs before and after a seven-day course of treatment. Bacteriological cultures demonstrated eradication or reduction of potentially pathogenic bacteria in 93.7% of eyes (ciprofloxacin) versus 88.9% of eyes (tobramycin), seven days after starting treatment. Clinically more than 80% of patients in both treatment groups were cured or improved after seven days. No statistically significant differences were observed between the two treatment groups. No serious side-effects were observed after use of either antimicrobial agent. Ciprofloxacin ophthalmic solution appears safe and effective. The spectrum of activity and clinical efficacy of this new formulation are discussed in comparison with currently used antimicrobial agents.

The results of this clinical study demonstrate that ciprofloxacin ophthalmic solution 0.3% is as safe and as effective as 0.5% chloramphenicol ophthalmic solution in the treatment of conjunctivitis and blepharitis of bacterial aetiology. Both agents achieved microbiological improvement rates in excess of 90% after 1 week's treatment. On ciprofloxacin 93.5% of patients were judged clinically cured or improved versus 84.6% on chloramphenicol after 1 week. There were no serious adverse affects. One patient in each group suffered drug-related side-effects (chemosis, erythema) which resolved on discontinuation or changing of therapy. Cirpofloxacin is not associated with the rare, but serious, side effect of aplastic anaemia which is associated with chloramphenicol use. On the evidence of this study ciprofloxacin would appear to be an appropriate agent for general use as a topical ophthalmic formulation.

Two hundred and eighty-four patients with acute conjunctivitis were enrolled in a double-masked study comparing norfloxacin ophthalmic solution with placebo. The proportion of patients who were clinically improved after 5 days treatment was 88.1% in the norfloxacin group and 71.6% in the placebo group (p less than 0.01). The proportion of patients who had all organisms eradicated, including the coagulase-negative staphylococci, after two to three days treatment was 52.7% for norfloxacin and 23.9% for placebo (p less than 0.01) and 64.7% and 26.3% (p less than 0.01) respectively when the coagulase-negative staphylococci were not included. Adverse experiences occurred in 4.2% of the patients receiving norfloxacin compared to 7.1% of the placebo patients. None of the adverse experiences was serious.

We investigated the efficacy and safety of norfloxacin 0.3% ophthalmic solution in 120 patients with bacterial conjunctivitis or blepharitis. Patients were selected for the study if they showed conjunctival hyperemia and at least three of the following criteria: a) symptoms of a surface ocular infection; b) a purulent discharge; c) crusting of the eyelids, and d) thickened, red lid margins. After taking a specimen for culture from the conjunctiva or skin-lash margin, the test drug was administered to the infected eye every two hours for one day, then 4 times daily for one week. Of the 120 patients who entered the study, 84.1% were cured. No serious adverse reactions occurred.