Trimethoprim.polymyxin ophthalmic solution versus …
I'llOrmolheropelllica
Vol. J. No. 4. 11)82
Trimethoprim.polymyxin ophthalmic solutio n versus chloramphenicol ophthalmic solution in the treatment of bacterial conjunctivitis
S. f. J. van Re nsburg,oJ. R. G ibson, S. G . Ha rvey and C. A. Burke
OKalafong Hospital and University of Pretoria . South Afr ica , and Clinical Investigat ion De partme nt , The Wellcome Research Laboratori es, Becke nham . England
PhUrmllllJeropelllicu , ( 1982). J, 274.
Paper receil'ed: 23rd Ju ne 1982
SUM M A RY
Forty patients wit h a d iagnosis of presumptive bacteri al conjuncti vilis we re treated wit h eithe r tri methoprim'polymyxi n or chloramphenicol ophthalmic solutio ns in a ra ndomi:ted, doub le? blind trial, No significant d iffere nces could be demonstrated betwee n the results of 1-days' treatmel\t with the two pre parat io ns and bot h solutions we re fo und to be e ffective in improving the signs and symptoms o f surface ocula r bacterial infection. No adverse react ions we re reported in e ither treatment group,
Key words: Trime thoprim - polymyxin - c hloramphenicol - ophthalmic solutions co njunctivitis, bacterial
II\;TRODUCTI ON
Trimethoprim-polym yxin B o ph thalmic solution has previously been show n to be a pro mising combina tion in the treatme nt o f surface ocular bac terial infections.2 In the study by O enee et a/,,2 this o ph thalmic solutio n was fo und to be as e(feclive as a c urrently marke ted ophthalmicsolulio n containing neomycin , polymyxin a nd gramicidi n, It was conside red to be of clinical interest , the refore. to assess fu rthe r the poten tial of this novel com bination by comparing it with c hloram phe nicol ophthalmic solutio n in the thera py of presumptive bacte rial conjunctivitis.
PATI ENT S AND Mt.'1I0 DS
Patie nts aged be tween 8 a nd 70 years incl usive with a clinical diagnosis o f surface ocular bacteri al infect ion were e nte red into the trial with the fo llowing e xcl usions: (i) those who had received Ireatme nt with o lhe r e ye pre parations o r syste mic antibiotics within the 72 ho urs prio r to the comme nceme nt of the trial, (ii ) those who had concomita nt fungus. virus, o r tube rcu lous infec lion o f the eye, (iii ) those who requi red conc urre nt trea tme nt with a syste mic or topical corticoste roid. antihistamine a nd/ o r a ntibio tic. (iv) those who had previously de monstrated allergic hype rsensitivity to c hloramphe nicol, polymyxin B or lrimethoprim . a nd (v) those who had contracted mo re than six surface oc ular bacterial infections during the 12 months prior to being considered fo r admission into the triaL Although the admission c rit e ria could theoretically have allowed the e nt ry of patie nts with a wide r spectrum o f d isease processes. in fac t all the patie nts e nte red had
Correspo/lde/lce 10: Dr. J, R. Gibson. The WeI/come Research Laborotor;eJ, Langley COIlf/. Beckenlram, Kent. BRJ JBS, ?/lg/ond
274
s. F J. 1'1I11 ReflSbu'8. J. R. GibJOII, S. G. Han?e)' and C. A. Burkff
presumptive bacte rial conjunctivitis. Informed conse nt was obtai ned in all cases. On entry, patients were allocated at random to receive treatmen t with either
trimethoprim-polymyxin B o phthalmic solution or chloram phenicol oph thalmic solu tio n. The trial was conducted in a double?blind fashion. Trimethoprim and polymyxi n B were present in the o phthalmic solut ion at a concentration of I mg/ ml and 10,000 units/ ml respectivel y. Chloramphenicol was present in the o phthalmic solution at a concentration of 5 rng/mt. The dosage of the preparatio ns used was I drop into each affected eye o-times daily for 7 days.
The patie nts were full y assessed clinically at the initial visi t and at a (o llow?up appointment 14 days ahe r starting therapy. In add ition, patients were requested to return promptly to the cl inic if there was no improvemen t in their conditio n aher 5 days of treatmen t.
The symptoms and signs assessed were as follows: itching, burning, foreign body sensa tion, grittiness, photophobia , wate ry o r purulent discharge, eyelids stuck together in the momi ng: eyelid effects - oedema, erythema and tenderness: eyelid margin effects - scales. erythema and ulceration: and meibomi tis. Symptoms and signs were scored according to a 0 to:) scale (O=not presenl, I=mild, 2= moder,lte and 3=severe ).
Swabs fo r bacte rio logical assessment were taken from the lower conjunctival sac at each visit a nd these were immediately plated onto blood agar and incubated at 37?C fo r at least 48 hours.
RESULTS
On completion of this study. 40 patients proved to be evaluable with regard to efficacy. Nineteen were in the trimethoprim?polymyx in group and 21 in the ch loramphenicol group.
The results o f the cl inical evaluation o f the patients a re summarized in Table I.
T.ble 1, Mea n scores and mea n redu ction in scores arter 7?days? treatment for symptoms and signs assessed in 40 patients
Signs and
Pre?trea tment
sym pt oms Burnin g
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