bacterial conjunctivitis
Conditions
Interventions
One drop of 1% SJP-0118 is instilled twice-daily (in the morning and in the evening) for 2 days, followed by once-daily (in the morning) for 5 days.
One drop of placebo is instilled twice-daily (in th
Sponsors
Senju Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Written informed consent obtained from the subject (or the subject's legally acceptable representative who ensures his/her maximum benefit when the he/she is under 20 years old) after adequate explanation on participating the study 2) Male or female outpatient aged 7 years or older at the time of obtaining consent 3) Diagnosis of bacterial conjunctivitis 4) Each score of eye discharge and hyperaemia >=1
Exclusion criteria
Exclusion criteria: 1) Possible ocular infection other than the trial indication 2) Possible allergic conjunctivitis or onset of its symptom during the study 3) Any history of recurrent erosion of cornea 4) Corneal findings of "+" or worse 5) Corrected visual acuity =<0.2 6) Instillation of any ophthalmic solution within 2 hours prior to the examinations on the start day of treatment 7) Systemic use, ocular instillation or topical dermal application around eyes of any antibiotic or synthetic antibacterial agent within one week prior to the start of treatment 8) Systemic use of corticosteroids or ocular instillation of corticosteroids or NSAIDs within one week prior to the start of treatment 9) Ocular surgery within 90 days prior to the start of treatment 10) Presence of a cancer or a serious systemic disease such as serious hepatic disorder, serious renal disorder, serious cardiovascular disease or serious endocrine system disease 11) Known history of allergy or significant adverse drug reaction to any ingredients of the drugs used in this study, azithromycin or other macrolide antibiotics 12) Past ocular instillation of azithromycin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical resolution will be assessed at day 3 and 7 according to Guidelines for the Clinical Trials of Antibacterial Ophthalmic Solution [Nippon Ganka Gakkai Zasshi. 2015;119(4)273-86]. | — |
Countries
Japan
Contacts
Public ContactYoshikuni Nakamura
Senju Pharmaceutical Co., Ltd. Planning & Medical Writing, Clinical Development
Outcome results
None listed