Study title:
A multi-centre, randomised, double masked, parallel-group study completed in the USA, Mexico and Brazil comparing the safety and efficacy of topical Ofloxacin 0.3% ophthalmix solution against that of topical Trimethoprim sulphate/Polymyxin B sulphate combination ophthalmic solution as a positive control, in infants, from birth to 31 days of age, with bacterial conjunctivitis.
Type of medicine: Medicines containing chemical active substances
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Therapeutic area: Bacterial Infections and Mycoses [01]
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Brands: Please see report |
MAH holders: Please see report, Please see report, Please see report |
Assessment: |
Active substance: OFLOXACIN |
ATC code: S01AX11
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Document link:
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Document date:
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Study number: 190442-005
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EudraCT number:
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Scope of study: CLINICAL |
Population of study subjects:
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Preterm newborn Infants
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Newborn infants
(1 to 27 days)
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Infants and toddlers
(28 days to 24 months)
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Children
(2 to 11 years)
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Adolescents
(12 to 18 years)
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-
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Y
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-
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-
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-
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