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Ofloxacin Compared with Chloramphenicol in the Br J Ophthalmol: First Published As 10.1136/Bjo.75.11.675 on 1 November 1991

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Ofloxacin Compared with Chloramphenicol in the Br J Ophthalmol: First Published As 10.1136/Bjo.75.11.675 on 1 November 1991 BritishJournal ofOphthalmology, 1991,75,675-679 675 Ofloxacin compared with chloramphenicol in the Br J Ophthalmol: first published as 10.1136/bjo.75.11.675 on 1 November 1991. Downloaded from management of external ocular infection A J Bron, G Leber, S N M Rizk, H Baig, A R Elkington, G R Kirkby, C Neoh, A Harden, T Leong Abstract agent against external ocular infections.6 The safety and efficacy of 0*3% ofloxacin in Ofloxacin is exceptionally potent against a wide treating bacterial ocular infections was com- range of Gram-positive and Gram-negative pared with that of 05% chloramphenicol in a bacteria and obligate anaerobes.78 It is effective parallel-group, randomised clinical trial at five in vitro against many organisms that cause ocular sites. Clinical and microbiological improve- infections (Table 1), for example Haemophilus ment rates were studied in 84 culture-positive influenzae, Neisseria gonorrhoeae, Staphylococcus patients. Patients with suspected bacterial species and Streptococcus species.90 Ofloxacin ocular infections were evaluated for clinical also acts against Pseudomonas aeruginosa," which improvement and were included in drug safety is associated with ocular infections that are and comfort analyses. Clinical improvement especially serious and difficult to treat. did not differ significantly between drug treat- Quinolones are bactericidal in mode ofaction; ments. All patients completing the study (79 they specifically inhibit the bacterial DNA assigned ofloxacin, and 74 chloramphenicol) gyrase supercoiling function required by showed clinical improvement. Clinical bacterial, but not eukaryotic cells.'2 In vivo, improvement in the culture-positive groups ofloxacin performs better than other fluoro- was 100% (41/41) after ofloxacin treatment, quinolones with similar in vitro MIC90 values and 95% (41/43) after chloramphenicol treat- (minimum concentration that inhibits 90% of ment. Microbiological improvement rates isolates in vitro).'3 The pharmacokinetic indica- were similar for the two drugs: 85% (33/39) tions'4 5 that it will be an effective topical ocular improved with ofloxacin, and 88% (38/43) antibiotic have also been confirmed by clinical improved with chloramphenicol. Both drugs tests.'6 Chloramphenicol, isolated from Strep- University ofOxford, were well tolerated. Adverse reactions pos- tomyces venezuelae in 1947, has been an effective Nuffield Laboratory of sibly due to the study medication occurred in agent against external ocular infections for about Ophthalmology 1% (1/89) of those who received ofloxacin, and 40 years.'7 Chloramphenicol acts by inhibiting A J Bron G Leber in 4% (4/93) of those who received prokaryotic protein synthesis.' The action of chloramphenicol. chloramphenicol is usually bacteriostatic, but it University Hospital, is bactericidal against Haemophilus influenza, http://bjo.bmj.com/ Queen's Medical Centre, Nottingham Streptococcus pneumoniae, and Neisseria menin- S N M Rizk Bacterial infection of the outer eye is common, gitidis. 19 H Baig but there is a limited range of antimicrobial Southampton Eye agents available for topical therapy. The search Hospital for new agents is influenced by the emergence of Patients and methods A Elkington resistant bacterial strains to some topical pre- This double-masked, parallel-group, clinical and by considerations of local and trial was conducted at five sites. Selected patients on October 1, 2021 by guest. Protected copyright. Birmingham and Midland parations Eye Hospital systemic toxicity. with suspected bacterial ocular infection were G R Kirkby In the following study the clinical efficacy of randomly assigned either 0 3% ofloxacin or 0 5% C Neoh ofloxacin, a new antibiotic, was compared with chloramphenicol ophthalmic solution for a Sussex Eye Hospital, that of chloramphenicol, an agent widely used seven-day treatment. Brighton against external bacterial ocular infections. This A Harden comparison was undertaken because chloram- T Leong phenicol resistance has become established in PATIENTS Correspondence to: A J Bron, Nuffield Laboratory several pathogens.'2 Moreover, rare but serious Patients were screened for several conditions. of Ophthalmology, University reactions have been associated with topical Other ocular disease, contact lens wear, and use ofOxford, Walton Street, Oxford OX2 6AW. ocular use ofchloramphenicol.-5 of other ophthalmic medications or of systemic Accepted for publication Ofloxacin, a synthetic fluorinated quinolone antibiotics were grounds for exclusion. Patients 2 May 1991 first described in 1982, shows promise as an sensitive to chloramphenicol or to any quinolone were excluded. Those with uncontrolled sys- temic disease and pregnant or nursing women Table I The in-vitro effect ofofloxacin compared wnth other topical ophthalmic anti-infective were not enrolled. Informed consent was agents againstfive major ocular pathogens, expressed as the MICs, the minimum inhibitory all enrolled concentration against 90% ofall bacterial strains tested." obtained from patients. MIC (pg/ml) SCHEDULE OF VISITS AND MEASUREMENTS Organism (no) Ofloxacin Gentamicin Tobramycin Chloramphenicol Symptoms were assessed by an ophthalmic Haemophilus influenza (18) 4 3-4 2 20 examination corrected visual slit- Pseudomonas aeruginosa (68) 4 8 4-4 128 (best acuity, Staphylococcus aureus (79) 0 5 1 2 16 lamp biomicroscopy, and ophthalmoscopy) at Staphylococcus epidermidis (68) 0-5 32 64 32 visit 1 (day 1), visit 2 (days 3-5), and visit 3 (day Streptococcus pneumoniae (21) 2 7 16 4 8). On day 1 ocular cultures were obtained from 676 Bron, Leber, Rizk, Baig, Elkington, Kirkby, Neoh, Harden, Leong ct-haemolytic streptococci (other than Br J Ophthalmol: first published as 10.1136/bjo.75.11.675 on 1 November 1991. Downloaded from Conjunctivitis 63% S. pneumoniae), Staphylococcus aureus, micro- cocci, and Branhamella catarrhalis, the threshold was more than 10. For class C other Staphylo- coccus species (including Staphylococcus epidermidis) and Bacillus species, the threshold }Missing 2% was more than 100. The threshold of class D, Corynebacterium species, was more than 10000 Keratoconjunctivitis 7% colony-forming units. Either eradication (zero colonies) or control of bacteria at visit 3 was scored as microbiological improvement. Bacteria were considered con- Blepharitis Blepharoconjunctivitis 20% trolled if the colony count dropped below threshold values. Figure I Distribution ofdiagnoses in 84 patients who entered the study with positive ocular microbiological tests. (Sum does not equal 100% owing to rounding error.) *One case of blepharokeratoconjunctivitis included under keratoconjunctivitis. CLINICAL IMPROVEMENT AND SAFETY all patients as described below. Investigators Clinical improvement was defined as a decline in applied the first drug dose, and patients were symptoms of external ocular infection. The instructed to use their eye drops every 2-4 composite severity score (CSS) of 10 factors (lid waking hours (according to severity as deter- erythema, oedema and crusting, palpebral and mined by the physician) on days 1 and 2 four bulbar conjunctival hyperaemia, conjunctival times daily on days 3 through 7, and to stop oedema and discharge, corneal oedema, foreign treatment at least 12 hours before visit 3 on day 8. body sensation, and pain) was determined for all Symptoms and drug tolerance were evaluated patients. Biomicroscopy and symptoms were at visits 2 and 3. A second ocular culture was graded 0 for none, 1 for mild, 2 for moderate, taken on visit 3 from patients whose first culture and 3 for severe. had given a positive result. Drug comfort was determined from reported irritation or pain following use of the drug. Safety was assessed by reported adverse MICROBIOLOGICAL METHODS reactions and by comparing visual acuity, lens Ocular cultures were obtained by rolling the tip pathology and ophthalmoscopy before and after of a calcium alginate swab, moistened with treatment. sterile unpreserved saline, along the lid margin and conjunctival cul-de-sac of each affected eye. After the culture sample was obtained, each OVERALL IMPROVEMENT swab was placed in a sterile tube containing 1-0 Overall improvement, defined as showing both ml of transport dissolving buffer solution microbiological and clinical improvement at visit http://bjo.bmj.com/ (sodium citrate dehydratee], sodium chloride, 3, was determined for initially culture-positive sodium acetate [trihydrate], potassium chloride, patients. calcium chloride dehydratee], magnesium chloride [hexahydrate], hydrochloric acid, sodium hydroxide, and purified water) and STATISTICAL ANALYSES delivered to the microbiological laboratory Clinical, microbiological and overall improve- within 4 hours for quantitative analysis. ment rates were compared by the Cochran- on October 1, 2021 by guest. Protected copyright. On arrival at the laboratory the transport tube Mantel-Haenszel (CMH) test22 stratified by the was vortexed until the swab fibres were finely investigator. The CSS of the treatment groups dispersed. A sample of the suspension was was compared by a two-way analysis ofvariance. directly plated on to a 5% horse blood agar plate For all analyses a p value less than or equal to (BAP) and a chocolate agar plate (CAP). A 1:10 0 05 was considered statistically significant. dilution of the sample was prepared in sterile trypticase soy broth and also plated onto BAP and CAP. All sample plates were incubated for Results 48 hours at 370C in 4% CO2. Colony-forming A total of 167 patients with
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